Lead Research and Development Engineer

3 weeks ago

Limerick, Ireland Cook Medical Full time

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, collaborate 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 Cooks 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, 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 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 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.

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