Overview
Who we are
PM Group is an employee owned, international project delivery firm with a team of 3,700 + people. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients and trade partners.
PM Group - Outsourced Technical Services (OTS) department is in search of a talented Design and Development Engineer who will be responsible for the design, development, and validation of innovative medical devices, ensuring compliance with regulatory standards. The role involves working closely with cross-functional teams to bring medical device products from concept to commercialization.
Responsibilities
Daily Responsibilities:
1. Lead the design and development of medical devices from concept through to manufacturing.
2. Develop 3D models, engineering drawings, and specifications.
3. Conduct feasibility studies, material selection, and risk analysis.
4. Prototype and test devices to ensure performance, safety, and reliability.
5. Develop and execute test protocols and reports for verification and validation (V&V).
6. Ensure compliance with medical device regulations and standards.
7. Work closely with regulatory teams to prepare technical documentation for CE marking and FDA approval.
8. Collaborate with manufacturing teams to optimize designs for production (DFM/DFA).
9. Support design transfer activities, including process validation and production scale-up.
10. Maintain design history files (DHF) and technical documentation as per quality system requirements.
11. Work within a multidisciplinary team, including R&D, Quality, Regulatory, and Manufacturing.
12. Stay up to date with emerging technologies and industry trends in medical devices.
Qualifications
Requirements & Qualifications:
1. Bachelor’s degree in Engineering or Science, preferably in Mechanical, Biomedical.
2. Project Management qualification an advantage.
3. 5+ years’ experience in medical device design or R&D with a successful track record of delivering products to market and product life cycle management.
4. Design verification, Design Controls, Change Control, Medical device design, research, and development, High volume manufacturing desired.
5. Polymer material science and injection moulding processes 3D CAD modeling and tolerancing.
6. In depth knowledge of design verification and design controls.
As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy.
Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.
PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
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