We are seeking a Senior/Staff R&D Engineer to join our Process & Technology Development team and play a key role in launching new products to treat stroke. The ideal candidate will have a strong background in mechanical engineering, metallurgy, and problem-solving skills, with experience in process optimization, corrosion testing, and statistical analysis. Key responsibilities include: Identifying and evaluating technologies for next-generation product platforms Implementing process technologies that are commercializable Improving corrosion results of metallic implants through process optimization Validating processes and test methods Generating and sharing data to inform key technical decisions Mentoring and developing cross-functional relationships Required qualifications include: Bachelor's or Master's degree in mechanical engineering or related discipline 2+ years of work experience in metallurgy and process optimization Strong problem-solving and analytical skills Experience with etching and passivation of metallic implants Knowledge of corrosion testing requirements for implants made from nitinol and/or other implant-grade materials Preferred qualifications include: PhD in engineering or science-related discipline Experience with PV and TMV
**Senior Manager, Sterility & Microbiology** **Lead a team of microbiologists to ensure completion of microbiological and bio-analytical testing, while managing sterilization controls and ensuring product quality requirements are met.** The Senior Manager, Sterilization & Microbiology will lead a team of microbiologists to ensure completion of all microbiological and bio-analytical testing. This includes special project/protocol testing in a timely and appropriate manner for all assigned sites. The successful candidate will be responsible for managing the Sterilization Controls Subsystem related activities for all assigned sites, partnering with Site/Divisional Business Quality Leads to ensure all local related quality metrics are met, and managing the Sterility Assurance teams for all assigned sites to ensure compliance with all quality and regulatory standards. **Key Responsibilities:** • Ensure product disposition plan attainment and that all products released meet the pre-determined quality requirements for all assigned sites. • Manage the Sterilization Controls Subsystem related activities for all assigned sites. • Partner with Site/Divisional Business Quality Leads to ensure all local related quality metrics are met. • Manage the Sterility Assurance teams for all assigned sites to ensure compliance with all quality and regulatory standards. • Assist in the implementation of quality and regulatory requirements (FDA, EU, GLP, and guidelines) and ensure compliance with testing SOP and specifications. • Monitor the testing techniques and accuracy of all records and documentation in the microbiology laboratory. • Initiate proactive functions to impact production, increase efficiency in the micro lab, solve problems generated during sterilization validation, and improve new product support in ECA and micro testing. • Evaluate performance via performance appraisal and ensure employee development plans are discussed as part of the annual performance review. • Conduct at least quarterly group meetings with the entire Sterility Assurance, micro, and quarantine service units to discuss future challenges. • Ensure all documentation is prepared, reviewed, and revised as required, including sterilization protocols, ECA excursions, micro investigations, TI, and specifications. • Establish environmental objectives and targets for continuous improvement across all assigned sites. • Combine regulatory guidelines with actual test results and practices to create knowledge for advancing quality improvement initiatives. • Supervise the Sterility Assurance Advisor and the Microbiology Laboratory and Product Disposition personnel for all assigned sites. • Coach and develop direct report subordinates. • Ensure inter-departmental compliance with company policies and corrective actions for all assigned sites. **Qualification Requirements:** • Bachelor's degree in science, Microbiology, or biological science preferred. • Master's degree desirable. • 10+ years of experience in a microbiology lab in medical device or pharmaceutical fields. • ISO Lead Auditor training is desirable. • Certified Quality Engineer (ASQ) is desirable.
What you will do: Lead risk management and usability activities for Joint Replacement products currently in the field in accordance with ISO 14971 and IEC 62366. Define strategy and execute on emerging issues (NC/CAPA, Regulatory Requests), Joint Replacement Lifecycle Management (Product Transfers, Supplier Initiated Change Requests), and Base Business Requests (Risk Management Periodic Review, EUMDR Compliance, Health Risk Assessments). Create and present guidance documents and internal trainings to cross functional teams on areas of experience for risk management and usability, as well as present externally in audits on our risk management files. Collaborate with cross functional partners from various groups including Product Development, Regulatory, and Clinical to solve technical problems regarding our existing orthopedic products Be a part of global initiatives to improve the cost and manufacturing on Stryker devices. Identify and lead continuous improvements projects within the Design Assurance team to implement new efficiencies into daily deliverables and large-scale tasks Be a part of a global team that drives engineering activities in the maintenance of orthopedic products to ensure the highest level of product quality and ensure compliance to the company’s quality system and external standards. Contribute to a team with whose mission is to efficiently drivesrigorin Sustainingactivities through creativeproblem solvingand ensures market continuity ofsafeandeffectiveproducts. What you need: Required: Minimum of 4 years experience in quality, engineering and/or risk management in a highly regulated industry. Bachelor's Degree in engineering Preferred: Experience with ISO 13485, ISO 14971 and IEC 62366. Experience in quality concepts (risk management, audits, NC/CAPA, HRAs). Strong interpersonal skills, written communication, and oral communication. #J-18808-Ljbffr
Principal Engineer, Automation & Technology - Stryker Limerick (23 month FTC) Hybrid Working Position Summary This role will provide technical leadership in the field of Automation and Technology for the facility. They will be a Subject Matter Expert in a controls and software related engineering discipline. This will involve working closely with leadership, contributing to, and supporting the overall automation & digital strategy for the site. What you will do: Lead multiple strategic Automation & Digitalisation projects, developing solutions in collaboration with cross functional teams. Champion automation and digitalisation excellence across the network. Benchmark and implement best practices across the network with respect to Automation and the latest in manufacturing technology. Conceptualise, design, and develop business intelligence tools in collaboration with end users that will be used to manage the business. Research new technology and industry best practices driving a culture of manufacturing innovation across the network. Lead initiatives in the standardization of digital tools and automated equipment, including the preparation of standards/specifications. Lead the development of standard user requirements for manufacturing equipment and system purchases in line with the site’s Automation and Technology strategy. Ensure full compliance with all regulatory, site and divisional requirements with respect to validation of equipment and software systems. Provide software design and automated controls technical leadership across the network. Lead and/or participate in equipment project review meetings ensuring vendors are meeting the software and hardware controls standards of Stryker. Technical leadership of engineers as required. What you will need: Level 8 Degree in Electrical/Electronic Engineering, Computer Science or related field with equivalent technical experience is required. Has a minimum of 8 years relevant experience in a manufacturing environment. An excellent technical background in software development and control systems is essential for this role (PLC, HMI, Robotics, Vision, Motion Control, SQL & Database Management). Strong working knowledge with Allen Bradley, Siemens & Ignition control systems is required. Strong working knowledge of scripting programming languages such as Go, C, Python, is required. Working knowledge of visualisation tools such as Power BI, building interactive dashboards, reports and data models that can visualise complex operational data. Experienced in the approach of Object Orientated Programming/Functional is required. Proficient in SQL for querying transforming and managing large datasets. Working knowledge in the curation of data and normalising to ensure data consistency and quality. Experience of working with Open Platform Communications such as OPCUA & Kepware are advantageous. Strong working knowledge of ISA95 and ISA88 design/implementation. Good knowledge of GMP / FDA & BSI regulatory requirements and current Health and Safety Regulations and legislation. A proven track record in designing, commissioning, validating, and maintaining automated solutions. A confident and effective decision maker, with a proven leadership ability to negotiate and influence others. A team player, with a flexible approach. Capable of working autonomously or as part of a multi-disciplined team in an aggressive, dynamic and results motivated environment. Technological pioneer, willing to source, investigate and implement technological and automation advances within our manufacturing processes. #J-18808-Ljbffr
Who we want Quality-focused team drivers . People who push their team to deliver the highest quality products and solutions in a timely manner. Network builders. Managers who build connections with other functions, teams, and business units and coordinate cross-functional collaboration. Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision. What you will do As an Associate Engineering Manager, Advanced Quality you will be responsible for leading a team of Advanced Quality Engineers supporting new product development within Stryker Orthopaedic Instruments. You will have cross functional responsibility and work closely with business unit leadership to deliver predictable, quality product launches. You will develop talent, advocate for, and drive team engagement. You will develop, coordinate, implement, and maintain QA systems for new products and business development. You will lead and coordinate the activities of Advanced Quality Engineers that are part of cross-functional NPD project teams and will provide Quality leadership for the broader NPD team. You will oversee and support Quality led tangibles such as risk management, human factors engineering, and design validation as well as adherence to design controls and QMS requirements. You will oversee and support process development and PPAP activities necessary to ensure manufacturing and supplier quality. You will train others in QA/GMP/SDLC related topics. You will be expected to operate autonomously and make decisions that are best for the business. You will evaluate the performance of the Advanced Quality Engineering team based on pre-established performance parameters. You will recruit, select, and on-board top talent You will develop talent within team to increase performance You will actively address performance issues on team You will deliver regular and timely feedback You will maintain a high level of team engagement What you need Bachelor’s degree in mechanical, electrical, or biomedical engineering, or related discipline. Master's Degree or equivalent preferred. Minimum of 6 years work experience. 5 years of experience in a regulated, new product development environment preferred. Experience in new product development, design controls, risk management, and HFE Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and international requirements. Demonstrate technical knowledge of medical device product lines. Demonstrated written, verbal, listening, communication, and team-building skills. Demonstrated ability to collaborate effectively with and lead cross-functional teams. Demonstrated ability to effectively prioritize and manage multiple project workloads. Demonstrated experience with trending and analysis reporting. Demonstrated leadership skills. Demonstrated process improvement and management skills. Experience with recruiting, people development. Knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics). Influence across the organization. #J-18808-Ljbffr
Who we want Detail-oriented process improvers . Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions. Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. Strategic thinkers . People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. In this role, you work within the quality assurance team, with responsibility for release activities, including, but not limited to the following: Review and approval of batch documentation (DHR) to acceptance specifications, prior to release of product. Batch documentation can consist of paper records and/or electronic data (CAQ, MES, ERP, etc.) Ensures compliance of batch documentation to internal requirements, GDP and identified regulations and standards. Executes system transactions to disposition product. Ensures acceptance and inspection activities for each product are established, appropriate, and carried out in accordance with procedures. Ensure that a consistent approach to acceptance and release is developed and maintained. Support FMEA and inspection development to ensure that all failure modes in process have been identified and addressed. Work closely with various business functions in terms of non-conformities in the batch documentation. Qualifications required BSc / B. Eng. in a science, engineering or related discipline preferred, or equivalent years of experience. 0 - 2 years experience in a manufacturing environment or equivalent. #J-18808-Ljbffr
Position Summary The Neurovascular Stroke Market is continuing to go through huge growth, driven by developments in new products to improve clinical outcomes, treat more patients and save more lives. We are hiring a Senior/ Staff R&D Engineer to join our Process & Technology Development team and play a key role in launching new products to treat stroke. Who we want This individual is responsible for identifying, evaluating and implementing technologies for next generation product platforms. People who bring strategic direction and drive for execution to ensure technology solutions are successfully implemented. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices. People who thrive in a fast-paced environment and can drive development innovative solutions that will enhance the experience of our customers. What you will do Join a technical team in research, evaluation, and implementation of technology solutions to unmet user needs. Identify, select and implement process technologies that are commercialisable. Will look at methods of improving the corrosion results of metallic implants through process optimization. Apply engineering theories, principles, and concepts across various products within business. Validate Processes and Test Methods. Generate and share data that can underpin key technical decisions. Mentor, develop and influence across the business, intentionally building divisional relationships. What You Need Required Bachelor's or Master's Degree in Mechanical Engineering, or related discipline. 2+ years of work experience. Metallurgy experience. Good problem solving and trouble shooting skills. A good understanding of statistical and analytical techniques. Excels at problem solving (Ability to work through each problem, use case, etc., and find the root-cause, then provide potential solutions; methodical 4D). Able to design & execute a test protocol. Preferred PhD in Engineering or Science related discipline. Experience with etching and passivation of metallic implants. Knowledge of corrosion testing requirements for implants made from nitinol and/or other implant grade materials. Experience with PV and TMV. #J-18808-Ljbffr
The Regulatory Affairs Specialist works closely under direct supervision to learn and develop the regulatory skills required to bring medical devices to market and ensure ongoing compliance. Participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluate proposed device changes. General Responsibilities: • Work with supervision, conferring with more senior staff when indicated. Keep supervisor regularly apprised of project status. • Participate in New Product Development Teams throughout all phases to ensure US, EU, and other international regulatory requirements are incorporated as part of the development process. • Evaluate medical device regulations and develop strategies for bringing products to market. • Contribute towards obtaining US and EU regulatory approvals by authoring, compiling, and submitting premarket regulatory applications. • Partner with global regulatory affiliates and leverage Reconstructive product expertise to provide submission documentation for expedited international market access and sustaining support. • Assess global impact of changes to launched products and support notifications/submissions as required. • Review labeling and marketing literature for compliance with regulatory requirements. Additional tasks may include: • Determining and communicating submission and approval requirements • Compiling, preparing, reviewing and submitting regulatory dossiers to authorities • Interfacing and coordinating directly with FDA, Notified Body reviewers, and other regulatory agencies on submissions, approvals or other issues. • Reviewing and approving change documentation for regulatory impact on launched products. • Providing regulatory input for and appropriate follow-up to inspections and audits. • Reviewing and approving labeling, advertising and promotional items for compliance before release. • Assisting in the development, implementation, and maintenance of regulatory procedures to ensure ongoing compliance of new and existing products. • Providing regulatory input for NCs. • Preparing and updating US product registrations and listings. • Assisting in the establishment and maintenance of regulatory information systems both electronically and hard copy. • Participating in process improvement activities and projects. • Assisting in complex projects and performing delegated tasks as required. • Assisting with product post-market or clearance requirements (progress reports, annual reports etc.). • Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements. • Identifying issues early in the submission preparation process that could impact product launch. • Communicating and negotiating with regulatory authorities and stakeholders under supervision of more experienced RA team members. • Ensuring project team(s) and RA management remain informed regarding all regulatory agency/Notified Body correspondence. Minimum Requirements: Bachelor’s degree in an Engineering, Science, or equivalent field 0-2 years in a Regulatory Affairs role #J-18808-Ljbffr
Scope of the role: Global Position summary Possesses and applies a broad knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. Key areas of responsibility Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature. Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance. Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions. Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.). Assists in the development of regulatory strategy and updates strategy based upon regulatory changes. Evaluates proposed products for regulatory classification and jurisdiction. Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities. Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization. Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes. Negotiates with regulatory authorities throughout the product lifecycle. Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation. Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance. Assists other departments in the development of SOPs to ensure regulatory compliance. Provides regulatory input and technical guidance on global regulatory requirements to product development teams. Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations. Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations. Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions. Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships. Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process. Provides regulatory information and guidance for proposed product claims/labeling. Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims. Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines. Monitors the progress of the regulatory authority review process through appropriate communications with the agency. Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools. Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees. Education / work experience BS in Engineering, Science, or related or MS in Regulatory Science. Typically a minimum of 4+ years relevant experience. RAC(s) preferred. #J-18808-Ljbffr
Senior Technician, Quality Reports To: Associate Manager/Manager, Quality Assurance Contract: 12 Month Contract Location: Springhill, Carrigtwohill Shift: Evening Shift. 3.00 pm - 11.00 pm (Some Flexibility). Key Areas of Responsibility To provide expert QA support to Operations, ensuring operational goals and objectives are achieved for the plant. Be a Subject Matter Expert with regard to Acceptable Quality Standards for products and processes. Ensure Regulatory compliance in area to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV). Represent QA as the first point of contact for daily line support issues. Troubleshoot product and process related issues and identify root cause. Work with QE’s and product teams to identify areas for risk reduction and error proofing processes and work on implementation of these. Drive awareness training with PTMs with the assistance of the manufacturing trainer. MRB: Provide input into the disposition for any non-conforming product and identify appropriate corrective action with other support team members. Perform internal quality audits. Trending and analysis of key Quality metrics. Assist in the preparation of periodic reports. All other duties as assigned. Qualifications Knowledge Skills Minimum qualification: Level 6 qualification in related quality discipline. Minimum of 2 years’ experience in a QA role. Knowledge of GMP regulated environment and experience in a similar role would be an advantage. Can manage obstacles and ambiguity. Experience/training in problem solving methodology. (Engineering Essentials TM) Builds strong relationships by fostering open communications, respect and trust. Is diplomatic, tactful and leverages excellent interpersonal skills to help achieve outcomes. Analytical & problem-solving skills, process improvement orientation, and the ability to handle multiple tasks in a fast-paced, results-oriented environment. Builds strong customer engagement and credibility by delivering on expectations and commitments. #J-18808-Ljbffr
