Overview: The Senior Manufacturing Engineer (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Find out more about Cook Medical here Responsibilities: Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards. Validate and implement medical device manufacturing processes as assigned. Identify equipment/fixture installation qualification requirements. Characterization of processes and their outputs/acceptance criteria. Written preparation of applicable validation reports that meet regulatory/company standards. Verification testing. Project management. Maintain accurate and timely reports and records. Must have excellent analytical and problem solving skills. Positive attitude, strong work ethic and self-motivated. Ability to handle multiple projects simultaneously and work with minimal supervision. Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth. Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and Cook’s Quality Management System where applicable. Delegate for Manufacturing Engineering Manager and the Senior Test Engineer. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications: Bachelor’s degree is desired, preferably in engineering or a related field and/or relevant experience. Minimum of 5 years’ Validation/relevant experience is required. Strong interpersonal and organisational skills and the ability to communicate at all levels of the organisation. Willingness to seek out and drive improvement. Proven project planning skills and the ability to execute projects in a timely and effective manner. Team Player with ability to develop strong working relationships. Demonstrated problem solving skills. Highly motivated individual, self-starter with a passion for excellence. Must be able to work in a fast-paced environment. Excellent attention to detail. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook’s products for global markets. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #J-18808-Ljbffr
Overview: Work collaboratively with the relevant Manager, Customer Support to ensure that daily operations of their team(s) run effectively with a primary focus on excellent services to customer, both internal and external. The scope of this role ranges from work load management to relevant HR related responsibilities. Reports to: Manager, Customer Support (Contracts, Tenders and Pricing) Find out more about Cook Medical here Responsibilities: Effectively manage the daily operations of their team(s) including phone priorities, daily and special tasks, effective query management & back order scenarios, ensuring that all daily targets and SLAs are met. Effectively manage team resources, including management of leave requests. Monitor adherence of team(s) to the EMEA Support Centre Quality Management System (QMS), ensuring that all procedure gaps are resolved and that daily, weekly & monthly stats are issued to the relevant parties. Work closely with the Quality team and Process owners to be audit ready. Focus on consistent continuous improvement within the team. Propose and support changes in relation to overall systems/process efficiencies. Act as the first point of escalation for individual, team, Divisional & customer issue(s) to find effective solutions. Become the process expert for Tenders & Pricing for relevant markets / customer groups, including new initiatives and Tender Regulations. Ensure that Tender submissions are managed effectively by the team. Ensure effective communications by holding regular individual 1:1’s, and team meetings; and attending and providing feedback from relevant department meetings. Be responsible for recruitment, including interviewing and new hire integration into the relevant team. Be responsible for performance management of team members, including completion of annual performance appraisals and performance improvement plans where relevant as well as support disciplinary procedures where necessary. Work closely the Training team to ensure that all team members, including new hires, are fully trained on all aspects of their roles. Highlight and address any training gaps as they arise. Coach and mentor all team members on best practice approach to their roles. Ensure that the Cook brand and image is communicated in a positive and consistent manner to all customers, both external and internal. Ensure all functions to be carried out in compliance with the company’s quality Management system. Qualifications: Relevant third level qualification advantageous. Previous experience of working with Pricing, Tenders and or Public Procurement advantageous. Previous experience of working in a contact centre / support centre environment advantageous. Previous experience working in a team leader role would be an advantage. Fluency in Italian and English. Strong leadership capabilities. Proven track record in problem solving. Ability to communicate effectively on an individual and group basis. Excellent organisational and prioritisation skills. Excellent knowledge of computer software packages. Strong customer focus. Self-starter and high self-motivation. Ability to multitask, attention to detail and accuracy essential. Excellent numeric and analytical skills. #J-18808-Ljbffr
Overview The Governance and Contracts Manager is responsible for the management of a portfolio of contractual agreements between Cook Medical and authorized HCPs (healthcare professionals). Working under the guidance of Director, GCA E&C, HCP Engagement, this position will draft and implement a range of contractual agreements, ensuring Cook Medical's contracts with HCPs operate in full compliance with all applicable legal and regulatory requirements within the GCA scope. This role will work closely with a broad range of Cook Medical functional units, including Ethics & Compliance, Legal and Finance, in addition to Vascular and MedSurg divisions. Responsibilities Review and assess proposals for the appointment of HCPs from a governance perspective. Conduct due diligence on HCPs Cook proposes to engage. Assess and report on due diligence results including red flag resolution and escalation. Identify, record and resolve potential conflicts of interest. Conduct fair market value assessment on HCP compensation. Manage a portfolio of HCP and facility agreements on behalf of Cook Medical. Manage and coordinate with the GCA team on all activities on assigned contracts and accurately record and report on contractual status of HCPs within the portfolio. Monitor ethics & compliance in respect to the engagement of HCPs in accordance with Cook Medical policies and procedures, in addition to all applicable laws and regulations. Under the guidance of Director, GCA E&C, HCP Engagement, draft and review legal contracts. Seek all necessary consents and authorisations for the appointment of HCPs and prepare all necessary submissions. Participate in projects aimed to streamline and enhance Cook's collaboration with HCPs globally in a transparent and ethical manner. Maintain contractual records and documentation (such as receipt and control of all contract correspondence, contractual changes, status reports and other documents) for all projects. Ensure that signed contracts are communicated to all relevant parties to provide contract visibility and awareness. Work with other functions within COOK to ensure monitoring and contractual compliance. Ensure timely contract close-out, extension or renewal. Keep leadership properly informed on a timely basis concerning actual and potential legal issues facing the business. Keep the organization's vision and values at the forefront of decision-making and action. Build strategic partnerships to further departmental and organizational objectives. Ensure that Cooks Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Relevant law degree or equivalent combination of education and work experience desirable. Demonstrates a strong comprehension of legal terminology. Strong attention to detail. Experience in regulatory and legal frameworks within the medical device industry preferred. Experience negotiating and drafting commercial agreements. Additional language skills advantageous. Excellent interpersonal skills with a track record of developing strong working relationships and working well within a multi-dimensional team. The ability to manage workload and make decisions/give advice independently. Excellent organizational skills. Comfortable working in a fast-paced environment; with a strong business acumen. Willingness & availability to travel on company business. #J-18808-Ljbffr
Overview: The Governance and Contracts Manager is responsible for the management of a portfolio of contractual agreements between Cook Medical and authorized HCPs (healthcare professionals). Working under the guidance of Director, GCA E&C, HCP Engagement, this position will draft and implement a range of contractual agreements, ensuring Cook Medical’s contracts with HCPs operate in full compliance with all applicable legal and regulatory requirements within the GCA scope. This role will work closely with a broad range of Cook Medical functional units, including Ethics & Compliance, Legal and Finance, in addition to Vascular and MedSurg divisions. Responsibilities: Review and assess proposals for the appointment of HCPs from a governance perspective. Conduct due diligence on HCPs Cook proposes to engage. Assess and report on due diligence results including red flag resolution and escalation. Identify, record and resolve potential conflicts of interest. Conduct fair market value assessment on HCP compensation. Manage a portfolio of HCP and facility agreements on behalf of Cook Medical. Manage and coordinate with the GCA team on all activities on assigned contracts and accurately record and report on contractual status of HCPs within the portfolio. Monitor ethics & compliance in respect to the engagement of HCPs in accordance with Cook Medical policies and procedures, in addition to all applicable laws and regulations. Under the guidance of Director, GCA E&C, HCP Engagement, draft and review legal contracts. Seek all necessary consents and authorisations for the appointment of HCPs and prepare all necessary submissions. Participate in projects aimed to streamline and enhance Cook’s collaboration with HCPs globally in a transparent and ethical manner. Maintain contractual records and documentation (such as receipt and control of all contract correspondence, contractual changes, status reports and other documents) for all projects. Ensure that signed contracts are communicated to all relevant parties to provide contract visibility and awareness. Work with other functions within COOK to ensure monitoring and contractual compliance. Ensure timely contract close-out, extension or renewal. Keep leadership properly informed on a timely basis concerning actual and potential legal issues facing the business. Keep the organization's vision and values at the forefront of decision-making and action. Build strategic partnerships to further departmental and organizational objectives. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications: Relevant law degree or equivalent combination of education and work experience desirable. Demonstrates a strong comprehension of legal terminology. Strong attention to detail. Experience in regulatory and legal frameworks within the medical device industry preferred. Experience negotiating and drafting commercial agreements. Additional language skills advantageous. Excellent interpersonal skills with a track record of developing strong working relationships and working well within a multi-dimensional team. The ability to manage workload and make decisions/give advice independently. Excellent organizational skills. Comfortable working in a fast-paced environment; with a strong business acumen. Willingness & availability to travel on company business. #J-18808-Ljbffr
Overview: The Manager, Research and Development will be responsible for leading Research and Development teams in the execution of product development projects in line with the Divisional program strategy. Reporting to: Senior Manager, Research and Development / Director, Research and Development Responsibilities: Manage, schedule, costs/budget and resources for project(s) assigned. Interact with physicians for deep clinical understanding and research new unmet needs in a clinical area. Technical responsibility for all Research and Development activities assigned. Improve team processes and systems for quality and delivery of work. Identifying new vendors and strategic partners for product development and component/subassembly supply. Maintain and improve high standard of medical device engineering. Works with other Research and Development Managers, Global Program Managers and Global Directors to ensure sharing of Research and Development best practice. Manage the development of the IP portfolio for their area of responsibility. Team Management: Mentoring, coaching and development of direct reports to attain best performance. Perform routine appraisals to deliver best results and to obtain the maximum team performance. Manage the activities of the Research and Development Engineering team and hold regular team meetings. Foster and maintain a workplace culture respectful and supportive of individual differences. Ensure KPI’s and business metrics are achieved. Ensure the Research and Development Engineering team are in compliance with Cook’s Quality System requirements and Company HR policies. Ensure team/teams deliver quality designs in a timely manner. Foster relationships and collaborate with other functional stakeholders required for the successful completion of development projects. Must ensure effective communication of project progress and risks to all relevant stakeholders. Must work and interact effectively and professionally with and for others throughout various levels of the global organisation. Must strictly adhere to safety requirements. Must maintain company quality and quantity standards. Ability to remain calm and receptive in fast paced situations. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications: Bachelor’s degree in engineering (preferably in Polymer Science, Industrial Chemistry or Pharmaceuticals) or related field is required and 10 years’ relevant experience. Strong proven people management skills – a minimum of 5 years previous experience in a supervisory position leading and motivating a group of talented engineering staff is desired. Proven project management skills. Strong technical writer. Good mechanical design, materials aptitude and understanding of engineering fundamentals with extensive medical device materials knowledge. Strong medical device experience with combination product. Extensive proven knowledge of requirements associated with technical transfers to Manufacturing Operations. Must have good understanding of IP process. Good working knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820), EU Medical Device Regulation 2017/745. Willingness and availability to travel on company business. About Cook Limerick: Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralized customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook’s products for global markets. Research and Development in Limerick: Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch. The R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD) and venous therapies. The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be a part of bringing a new product onto the market. All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid #J-18808-Ljbffr
Overview: This role will lead a team of engineers focused on research, development, and implementation of new medical device designs. This role will be responsible for technical leadership within the project team which could include signing off on deliverables and supporting the training and delegation of work responsibilities to other engineers on the team. Reporting to: Manager, Research and Development / Senior Manager, Research and Development Responsibilities: Lead project teams or provide technical leadership for medium to large scale Research and Development projects, collaborating to provide technical leadership across the department and/or multiple projects in a specific area or subject matter expertise. Lead a team in the development of chemical and physical analytical methods to support early stage product development. Drive capacity analysis within the Pharmaceutical Development Formulation team to ensure optimal and efficient use of resources and equipment. Collaborate with internal and external team members in identification and evaluation of Critical Material Attributes (CMAs). Drive improvement initiatives in area of expertise, which may include process ownership for department. Where appropriate, apply lean principles to the design and implementation of new processes. Responsible for approval of work product or work for project teams. Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved in collaboration with project manager (when one is assigned). Work closely to build effective relationships with cross functional groups to achieve project and company goals. As part of project/technical leadership, responsible for: Leading technical development of projects. Leading all key design decisions to ensure quality of design selection to meet customer needs. Retrospective project reviews to understand lessons learned. Managing device evaluations and compliance with Quality, Regulatory and company policies and systems. Ensure all work undertaken within the team complies with current guidance and Industry best practice e.g. USP, Ph Eur (V), ICH. May represent Cook in industry standards, working groups and present on Cook's behalf in industry conferences. Act as a mentor to other personnel in the department. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications: Bachelor’s degree in engineering (preferably in Polymer Science, Industrial Chemistry or Pharmaceuticals) or related field required and 7 years’ relevant experience OR Master’s Degree and 5 years’ relevant experience OR PhD and 4 years’ relevant experience. Experience in Product Development projects within Medical Device - specifically combination product experience. An excellent understanding of technologies (and challenges) associated with formulation and product development. Competent in chemical and physical analytical methodology and testing procedures necessary for the development and approval of successful formulations. Extensive proven knowledge of requirements associated with technical transfers to Manufacturing Operations. Proven project/technical leadership. Project management methodology and skills. Proven experience working closely with project managers. Knowledge of relevant ISO, EU, FDA medical device standards regulations is required. About Cook Limerick: Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralized customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook’s products for global markets. Research and Development in Limerick: Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch. The R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD) and venous therapies. The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be a part of bringing a new product onto the market. All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid #J-18808-Ljbffr
Overview: The primary responsibility of this position is to support / lead on the design, development and taking to market of medical devices for Cook Medical. Reporting to: Team Lead, Research and Development / Manager, Research and Development Responsibilities: Perform Duties of Research & Development Engineer 2: Design development, prototyping, test method design, design evaluation, design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely effective manner. Product testing and evaluation, completion of test reports to support design selection. Preparation and presentation of design reviews. Product risk analysis and risk management. Contribute towards process development during introduction /development of new equipment and production processes as required for any new manufacturing techniques. Source new materials components and equipment. Development of component specifications, inspection methods, bills of materials and manufacturing processes. Introduction of new equipment, materials and technologies. As required work closely with Key Opinion Leaders, physicians, product managers and team to develop innovative medical devices to improve patient care. Work closely with Project Lead and take responsibility for assigned research and development project tasks: Manage and drive assigned project tasks to ensure timely completion of project milestones. Work closely with cross functional groups to achieve project and company goals. Product performance evaluations. Contribute to innovation and creativity within team through filing of disclosures and patents. Hold regular project meetings and document minutes and actions. Ensure project milestones are achieved to meet business metrics. Communications: Regular communication to cross-functional teams and senior management. Project status communications and reporting. Remain on the forefront of emerging industry practices. Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products. Support other cross functional groups to deliver company goals. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications: Bachelor’s degree is required, preferably in engineering or a related field. Minimum of 3 years’ relevant experience is desired. Project planning/execution skills. Execution of project in a timely effective manner. Knowledge of anatomy and physiology. Good mechanical design and understanding of engineering fundamentals with medical device materials knowledge. Statistical understanding and experience. Manufacturing design and process understanding. Good working knowledge of Solidworks and/or Pro Engineer CAD. Strong technical writer. Knowledge of relevant ISO, EU, FDA medical device standards regulations is required. Willingness and availability to travel on company business. About Cook Limerick: Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook’s products for global markets. Research and Development in Limerick: Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch. The MedSurg R&D team in Limerick has two programs, Endoscopy/EndoSurgery and Otolaryngology Head and Neck Surgery (OHNS) that it is responsible for designing and developing new and innovative products for. The R&D engineers and scientists have the opportunity to explore and create novel ideas within feasibility, bring a medical device through verification and validation phase and be a part of bringing a new product to the market. The MedSurg R&D team works in collaboration with Cook’s sister site in Winston Salem, North Carolina. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid #J-18808-Ljbffr
