embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. Responsibilities: Be a primary contact for other departments providing quality guidance to assure compliance. Manage compliance with relevant GMPs and promote quality improvements. Review quality records including batch history records and other Quality documentation as required. Maintain all batch history records and related documentation. Work with cross-functional teams to support product release. Prepare technical documentation. Support the coordination and maintenance of the Documentation System. Collate, review and report on process performance at department and site levels. Be a key member of the site audit team, supporting all Regulatory and Customer audits. Attend and contribute to departmental and other meetings. Provide support for the Quality Management System as determined necessary by Quality Management. Educational Requirements and Relevant Experience: Science/Engineering qualification Experience working within an established Quality System Knowledge, Skills and Abilities: Excellent interpersonal and communication skills The ability to work progressively as part of a team and on own initiative Eager to learn and follow direction Excellent attention to detail #LI-MP2 embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. The plant, based in Dun Laoghaire, runs 24/7 and is the Worldwide Centre of Excellence for Pen Needle Manufacturing within the embecta organisation, producing 4.6 billion medical devices annually. Here we employ approximately 450 people across operations, engineering, quality and R&D. We are now inviting application for our PQS Operator Talent Pool to (11-Month Fixed Term Contract) whose role is to meet operational needs across the site. This includes monitoring and maintaining production and quality performance to meet specified standards in accordance with GMP. This is a busy and varied role. Main responsibilities will include: The Operator will carry out the full range of responsibilities and duties required to meet current and future operational needs. This includes monitoring and maintaining production and quality performance to meet specified standards. Routine adjustments, repairs and maintenance of machines will be carried out by Operators. Operators will carry out all duties in line with Good Manufacturing Practices (GMP) and will record production and testing data in line with Standard Operating Procedures (SOPs). Operators will use existing technology and will embrace any requirements to acquire additional skills for new tools/equipment etc. Operators will participate in initiatives, projects & teams as required including Continuous Improvement, QIP (Quality Improvement Programme), Lean and 6 Sigma type teams. Must have excellent written and verbal communication skills as well as the ability to accurately document work performed. Ability to work primarily on your own initiative but experience working as part of a team will be required occasionally - You need to have a Strong planning and organizational ability. About you The successful candidate will have a minimum of 3 years' work experience in a manufacturing environment. You will have knowledge of using IT systems such as manufacturing. Regulated manufacturing/production environment and have a proven ability and willingness to learn. You will be technically qualified with a Leaving Certificate or substantial GMP manufacturing experience and a third level qualification in a technical discipline is desirable. You will need to have an excellent interpersonal and communication skills to execution systems, online self-service portals, training systems and barcode scanners required. Experience of working in a highly automated and high-speed environment and in a controlled clean room environment would be a distinct advantage. You will be hands on and have a sense of urgency. Ability to function as part of a team and work on own initiative. The ideal candidate will have some GMP/GDP experience and high level of safety awareness. This role will include Shift work, previous experience of Shift patterns is required. You must be willing to work on a 4-shift basis, the company will operate 24 hours/day, 7 days/week. embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Overview Quality Systems Coordinator at embecta embecta is a global diabetes care company that leverages its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Our Total Rewards program includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components to support our diverse and global workforce. Responsibilities Be a primary contact for other departments providing quality guidance to assure compliance. Manage compliance with relevant GMPs and promote quality improvements. Review quality records including batch history records and other quality documentation as required. Maintain all batch history records and related documentation. Work with cross-functional teams to support product release. Prepare technical documentation. Support the coordination and maintenance of the Documentation System. Collate, review and report on process performance at department and site levels. Be a key member of the site audit team, supporting all regulatory and customer audits. Attend and contribute to departmental and other meetings. Provide support for the Quality Management System as determined necessary by Quality Management. Educational Requirements and Relevant Experience Science/Engineering qualification Experience working within an established Quality System Knowledge, Skills And Abilities Excellent interpersonal and communication skills Ability to work progressively as part of a team and on own initiative Eager to learn and follow direction Excellent attention to detail embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. Seniority level Entry level Employment type Full-time Job function Quality Assurance Industries Medical Device #J-18808-Ljbffr
IT Infrastructure and Application Engineer embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life’s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees. The IT Infrastructure and Application Engineer will be responsible for overseeing the day-to-day IT operations at a manufacturing facility, ensuring the smooth functioning of the site\'s technology infrastructure and providing application support. This role is vital to maintaining operational continuity and driving digital efficiency in a fast-paced production environment. Respectful, focused responsibilities Provide technical support and troubleshooting for manufacturing applications and software used on-site. Collaborate with site-based Manufacturing teams within Operations, Process Engineering, Product Development, and Business Functions (Quality, Supply Chain, Finance, Facilities, HR, etc.) to improve user experience, solve business problems, and help deliver new technical solutions. Be the technical owner for local business systems, collaborating with vendor support teams. Manage the end-to-end support of applications and infrastructure. Maintain documentation for system configurations, processes, and support activities. Respond to IT incidents, diagnose root causes, and implement corrective actions. Provide hands-on support, guidance, and expertise for the adoption of new tools, processes, or workflows. Facilitate the understanding of business needs for system enhancements and upgrades. Responsibilities Work with third party provider On-Site Support to provide day-to-day operational IT support. Local IT budget oversight and management. Drive technology improvements that enhance site productivity and manufacturing operations. Interface with OT teams on infrastructure, security, and application needs. Creatively solve local needs using low or no-code solutions like Microsoft Power Apps and CoPilot. Provide an escalation point for when service levels are missed or at risk and coordinate resolution with infrastructure, change, and support teams. Provide local application support as needed. Translate business impact to technical teams, and vice versa. Deskside and remote IT support as needed, including onboarding, routine remote support, technology deployments and employee offboarding for remote Europe locations. Support the resolution of business operational issues. Collaborate with Business and Operations Leaders to build productive relationships. Drive Global and Local IT projects at the site across all technology towers. Coordinate with partner teams to ensure delivery of desired outcomes. Drive technology adoption and training. Demonstrate technical leadership and influence beyond the immediate team. Work with other IT teams for continuous improvement of the overall IT organization. Coordinate across geographically distributed teams and focus on continuous process improvement and user experience by increasing IT\'s value through innovation and emerging technologies. In addition, this person should also possess Experience in manufacturing or supply chain technologies and systems such as SAP ERP, MES, OT applications. 5-7 years of experience in IT. Experience overseeing outsourced IT providers and working with a variety of third-party providers to achieve business goals. Strong knowledge of global technologies, including productivity suites, networking, end-user platforms, and cloud hosting platforms. Superior analytical, evaluative, and problem-solving abilities. Excellent judgment and decision-making. Knowledge in network operations and/or application management. Experience supporting manufacturing or industrial environments preferred. Able to align and work with diverse global stakeholders. Strong humility, listening, and creativity. Familiarity with LAN/WAN technologies. Familiarity with Microsoft Office, Visio, Project, O365, SharePoint, OneDrive, Active Directory, Messaging, DNS, Site & Services, Group Policies, Intune, CoPilot. Extensive experience in troubleshooting issues. Self-motivated with a drive for delivery and customer focus. Excellent interpersonal skills with the ability to influence at all levels. embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. Seniority level Entry level Employment type Full-time Job function Information Technology Industries Medical Device Copyright: embecta #J-18808-Ljbffr
Join to apply for the PQS Operator role at embecta 3 days ago Be among the first 25 applicants Join to apply for the PQS Operator role at embecta Get AI-powered advice on this job and more exclusive features. embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visitembecta.comor follow our social channels onLinkedIn,Facebook,InstagramandX. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life’s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees. The plant, based in Dun Laoghaire, runs 24/7 and is the Worldwide Centre of Excellence for Pen Needle Manufacturing within the embecta organisation, producing 4.6 billion medical devices annually. Here we employ approximately 450 people across operations, engineering, quality and R&D. We are now inviting application for our PQS Operator Talent Pool to (11-Month Fixed Term Contract) whose role is to meet operational needs across the site. This includes monitoring and maintaining production and quality performance to meet specified standards in accordance with GMP. This is a busy and varied role. Main Responsibilities Will Include The Operator will carry out the full range of responsibilities and duties required to meet current and future operational needs. This includes monitoring and maintaining production and quality performance to meet specified standards. Routine adjustments, repairs and maintenance of machines will be carried out by Operators. Operators will carry out all duties in line with Good Manufacturing Practices (GMP) and will record production and testing data in line with Standard Operating Procedures (SOPs). Operators will use existing technology and will embrace any requirements to acquire additional skills for new tools/equipment etc. Operators will participate in initiatives, projects & teams as required including Continuous Improvement, QIP (Quality Improvement Programme), Lean and 6 Sigma type teams. Must have excellent written and verbal communication skills as well as the ability to accurately document work performed. Ability to work primarily on your own initiative but experience working as part of a team will be required occasionally - You need to have a Strong planning and organizational ability. About You The successful candidate will have a minimum of 3 years' work experience in a manufacturing environment. You will have knowledge of using IT systems such as manufacturing. Regulated manufacturing/production environment and have a proven ability and willingness to learn. You will be technically qualified with a Leaving Certificate or substantial GMP manufacturing experience and a third level qualification in a technical discipline is desirable. You will need to have an excellent interpersonal and communication skills to execution systems, online self-service portals, training systems and barcode scanners required. Experience of working in a highly automated and high-speed environment and in a controlled clean room environment would be a distinct advantage. You will be hands on and have a sense of urgency. Ability to function as part of a team and work on own initiative. The ideal candidate will have some GMP/GDP experience and high level of safety awareness. This role will include Shift work, previous experience of Shift patterns is required. You must be willing to work on a 4-shift basis, the company will operate 24 hours/day, 7 days/week. embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. Seniority level Seniority level Entry level Employment type Employment type Full-time Job function Job function Management and Manufacturing Industries Medical Device Referrals increase your chances of interviewing at embecta by 2x Sign in to set job alerts for “Manufacturing Operator” roles. Dublin, County Dublin, Ireland 14 hours ago Dublin 6, County Dublin, Ireland 2 weeks ago Dublin, County Dublin, Ireland 3 weeks ago Dublin, County Dublin, Ireland 2 days ago Dublin, County Dublin, Ireland 3 weeks ago Manufacturing Operator -23 month temporary contract Dublin, County Dublin, Ireland 11 hours ago Laboratory Test Technician (GMP Medical Devices) Dublin, County Dublin, Ireland 1 week ago Dublin, County Dublin, Ireland 1 month ago Quality Control Technician - 23 Month Contract Dublin, County Dublin, Ireland 3 months ago Maintenance Technician - Manufacturing (FT Contract) Dublin, County Dublin, Ireland 1 month ago Dublin, County Dublin, Ireland 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Overview embecta is a global diabetes care company that leverages its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X. This is a remote role Summary The position of the GRL Lead Graphic Designer plays a key role in supporting global compliance by designing and maintaining high quality, compliant artwork for medical devices (i.e., product labeling and instructions for use) with embecta’s product portfolio (i.e., injection products, new product development products, private labeled products, and M&A growth initiatives). This position works cross-functionally with project teams to ensure artwork content meets global requirements and supports product availability across all regions. Responsibilities Collaborate with Project Lead to fully understand scope of graphics and labeling projects Communicate artwork considerations and timelines to Project Leads and stakeholders Recommend and contribute ideas for packaging and labeling strategies using package labeling knowledge from historical data and material characteristics Design artwork for product labeling (defining format/graphic requirements) using Adobe Creative Cloud (Illustrator, InDesign, Acrobat, Photoshop) from input provided by Regulatory, Marketing, R&D, and other departments Coordinate translation of product labeling to meet international regulatory requirements Serve as a brand steward, developing and enforcing visual style guides and standards for all creative assets, including private label branding agreements Review and approve graphics with Project Lead and cross-functional teams in accordance with SOPs and project timelines Participate in sustaining injection projects, new product development, private label programs, and/or M&A growth initiatives as the GRL core team member Ensure compliance with Graphics roles and responsibilities outlined in applicable SOPs Execute process improvement related to artwork creation, review, and approval workflows, efficiencies, and standardization Mentor junior GRL team members, providing constructive guidance and feedback Organize and lead regular design reviews and knowledge-sharing sessions to maintain high quality standards Educational Requirements and Relevant Experience You should possess a primary degree in graphic design, or equivalent, and be familiar with the latest graphic design software. Experience in a regulated healthcare environment within a graphics and labeling function is a distinct advantage. Knowledge, Skills and Abilities 5+ years of experience in Medical Device and/or Pharmaceutical graphics, proofreading, and labeling development Proficient in Adobe Graphics software and text comparison and image comparison proofreading software Experience with Barcode creation and GS1 standard (advantage) Familiarity with global medical device labeling requirements including FDA (21 CFR 801), EU MDR, ISO standards, and related guidance Excellent knowledge of print production and processes with high attention to detail and experience producing high quality documentation under tight timelines Flexibility in meeting constantly changing demands Strong verbal and written communication skills, including ability to collaborate with technical and non-technical stakeholders Must be able to work Irish local time (GMT/GMT+1 depending on daylight savings) in alignment with the embecta Penel Limited office in Dun Laoghaire, Ireland embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. Job Details Seniority level: Mid-Senior level Employment type: Full-time Job function: Design, Art/Creative, and Information Technology Industries: Medical Device Get notified about new Lead Graphic Designer jobs in County Dublin, Ireland. #J-18808-Ljbffr
Overview Join to apply for the Associate Director, Pen Injector Product Development role at embecta embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visitembecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X. Why join us A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life’s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees. embecta, formerly part of BD, is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships, and the passion of more than 2,000 employees around the globe. Role summary This role leads the development of core technologies within R&D, guiding strategic direction across innovation projects. You’ll evaluate emerging trends, advise on future technology choices, and help build lasting technical expertise to drive product advancement. Responsibilities Partner with key stakeholders across the various functions, to align objectives by understanding market opportunities, strategic goals and roadmaps Develop, implement, and coordinate strategies as they relate to Pen Injectors and Auto Injectors Understand the current market landscape of pen injectors and auto injectors, their strengths and weaknesses and associated opportunities for embecta. Ensure that all new products are Designed For high volume Manufacturing and Assembly (DFMA) Follows design, quality, and safety guidelines based on GMP, FDA, and ISO guidelines and related embecta Quality and Safety Standards and Practices Leads and motivates a lean, high performing team in the development of new products that increase revenue for embecta with a short payback period and quick launch windows. Leverage the Engineering Group in Dún Laoghaire, Ireland in alignment with the Director of the Engineering Group. Bring an exciting energy to the Dún Laoghaire team, identifying high potential candidates for development and possible rotation through the Pen Injector Development Team. Education And Experience Bachelor's degree in Mechanical Engineering or related technical field is required; advanced degree is a plus Minimum of 15 years relevant experience in successful cross-functional matrix organizations 10+ years of experience in medical industries developing mechanical-based consumable Medical Devices Experience working with and managing internal talent, as well as third-party consultants and service providers Excellent presentation and communication skills, including executive presentation Superior analytical, evaluative, and problem-solving abilities embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. Seniority level Director Employment type Full-time Job function Product Management and Marketing Industries Medical Device Referrals increase your chances of interviewing at embecta by 2x #J-18808-Ljbffr
embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. embecta, formerly part of BD, is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships, and the passion of more than 2,000 employees around the globe. This role leads the development of core technologies within R&D, guiding strategic direction across innovation projects. You'll evaluate emerging trends, advise on future technology choices, and help build lasting technical expertise to drive product advancement. Responsibilities Partner with key stakeholders across the various functions, to align objectives by understanding market opportunities, strategic goals and roadmaps Develop, implement, and coordinate strategies as they relate to Pen Injectors and Auto Injectors Understand the current market landscape of pen injectors and auto injectors, their strengths and weaknesses and associated opportunities for embecta. Ensure that all new products are Designed For high volume Manufacturing and Assembly (DFMA) Follows design, quality, and safety guidelines based on GMP, FDA, and ISO guidelines and related embecta Quality and Safety Standards and Practices Leads and motivates a lean, high performing team in the development of new products that increase revenue for embecta with a short payback period and quick launch windows. Leverage the Engineering Group in Dn Laoghaire, Ireland in alignment with the Director of the Engineering Group. Bring an exciting energy to the Dn Laoghaire team, identifying high potential candidates for development and possible rotation through the Pen Injector Development Team. Education and Experience Bachelor's degree in Mechanical Engineering or related technical field is required; advanced degree is a plus Minimum of 15 years relevant experience in successful cross-functional matrix organizations 10+ years of experience in medical industries developing mechanical-based consumable Medical Devices Experience working with and managing internal talent, as well as third-party consultants and service providers Excellent presentation and communication skills, including executive presentation Superior analytical, evaluative, and problem-solving abilities #LI-HYBRID #LI-DF1 embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. As part of the embecta diabetes team, the Senior Manager, Program / Project Management, is a strategic leader responsible for driving the successful execution of high-impact projects that align with organizational goals. This role involves leading cross functional teams, optimizing resource allocation, and fostering strong relationships with key stakeholders. The Senior Manager will ensure that projects are delivered on time, within scope, and within budget, while continuously seeking opportunities for process improvement and innovation. Responsibilities Program Management Lead cross-functional teams coordinating multiple R&D projects, ensuring compliance, form/fit/function, cost savings, line extensions, and other business opportunities across all plants. Ensure projects are delivered on time, within scope, and within budget, leveraging extensive experience to manage complex project portfolios and navigate regulatory requirements specific to the medical device industry. Strategic Planningand Execution Lead the development and implementation of strategic project management initiatives to ensure alignment with organizational goals and objectives. Team Leadershipand Development Mentor and guide cross-functional teams, fostering a collaborative and innovative environment. Provide leadership and mentorship to team members, leveraging experience to develop their skills and capabilities. Stakeholder Communication Build and maintain strong relationships with key stakeholders, ensuring effective communication and collaboration throughout the project lifecycle. Risk Management Identify, assess, and mitigate project risks, ensuring that potential issues are proactively addressed and resolved. Budget Management Develop and manage program budgets, ensuring efficient allocation of resources and adherence to financial constraints. Utilize financial acumen to optimize budget management and ensure cost-effective project execution. Performance Monitoring and Reporting Establish and maintain project performance metrics, providing regular updates and reports to senior leadership on project status, progress, and outcomes. Process Improvement Drive continuous improvement initiatives within the project management function, identifying opportunities for enhanced efficiency, effectiveness, and innovation. Compliance and Governance Ensure that all projects adhere to organizational policies, standards, and regulatory requirements. Education & Experience Bachelor's Degree in an engineering discipline, Masters preferred PMP certification a plus A minimum of 7 years of project management experience; 3 years of program management. Experience managing programs in a regulated industry preferred Experience with global initiatives required Expertise in advanced project management methodologies and tools, including Agile, Lean, and Six Sigma. Experience in strategic planning and execution, aligning project goals with organizational objectives. Focus on regulatory compliance, including experience with audits and ensuring adherence to industry standards. Skills and Abilities Leadership and Mentorship Strong leadership skills, including the ability to mentor and develop cross functional team members. Stakeholder Engagement Proficient in stakeholder management, including building and maintaining relationships with key stakeholders. Resource Optimization Skills in optimizing resource allocation, including personnel, budget, and technology. Strategic Decision-Making Ability to make strategic decisions that align with organizational goals. Change Management Capability to drive change within the organization, including leading change management initiatives. Performance Monitoring Ability to establish and maintain project performance metrics, providing regular updates to senior leadership . #LI-HYBRID #LI-DF1 embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Overview Join to apply for the Validation & Verification Engineer role at embecta embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visitembecta.comor follow our social channels onLinkedIn,Facebook,InstagramandX. Responsibilities Develops new or optimizes existing physical test methods and test fixtures to support the design verification, validation and commercialization of new medical device products and changes to existing products. Drafts engineering technical reports, test method work instructions or procedures and test method validation related documents. Leads/executes test method validation (TMV), design verification and test method transfer, in support of product design verification or validation Authors design verification protocols to satisfy product design inputs/system requirements, that satisfy applicable Quality System (QS) and regulatory requirements Manages and tracks product configurations through design verification and validation Performs hands-on and simulated testing for design verification and test method developments Conducts functional and performance testing of products to ensure that the product and its components meet the required specifications Identifies and reports out of specification results, data, and atypical/unexpected events that occur during testing activities and supports associated investigations, impact assessments and Root Cause Analysis (RCA) Educational Requirements Minimum of Bachelor’s degree in Engineering 3+ years of professional experience in the medical device, pharmaceutical or life sciences field. Relevant Experience Applied experience in developing and qualifying test systems and methods in support of product development and launch (IQ, OQ, Measurement Systems Analysis (MSA), etc.) Experience with executing Design Verification Experience in statistical data analysis methods / tools, e.g.: Gage R&R, Hypothesis Testing Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions Knowledge, Skills And Abilities Disciplined and well organized Excellent multi-tasking, analytical, communication, and prioritization skills. Ability to work independently with minimal supervision as well as in a team environment embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. Seniority level Entry level Employment type Full-time Job function Quality Assurance Industries Medical Device #J-18808-Ljbffr
