Lead, Product Engineering, MedTech Catapult

The MedTech Catapult is a national initiative for accelerating the development of high-value MedTech projects through an in-house product engineering unit. The objectives of the Productization Unit is to design and develop technologies through the medical device development cycle to produce full-fledged hardware product systems in tandem with partners. The Lead of R&D will report to the Programme Director and lead a team of 5 to 9 engineers.
Job Responsibilities:

• Lead and manage diverse engineering team to translate technologies through product development and engineering across a full-life cycle of product development and from proof of concept/feasibility to pilot production.

• Execute complex engineering projects by applying deep working knowledge of the technology trends - emerging technologies, sustainability, bringing teams through design & development, risk analysis, verification and validation whilst applying best practices for development and testing in terms of design patterns, reusable components, and automation etc as applicable.

• Lead the development of intellectual property portfolio in device design and process technology know-how.

• Knowledgeable in industry standards and regulation and author/guide policies, procedures, including coaching of new employees.

• Work with both internal and external stakeholders to define project plans and budgets, develop and maintain project timelines, establish and monitor project risks and risk register and lead the project teams to achieve project deliverables and objectives in accordance to ISO 13485.

• Interface with external parties (design houses) to communicate product requirements, and subsequent knowledge transfer to build internal capability.

• Review and approve documentation for QMS, approve risk analysis, risk management, verification and validation procedures.

• Apply disciplined, fact-based judgment to process recommendations.

• Consistently demonstrate structured thinking.

• Manage resources allocated to the PU efficiently.

Requirements:

1. M.S in Electrical Engineering, Computer Engineering or Mechanical Design.

2. 15+ years of experience in medical device industry in R&D, and/or related area.

3. Experience in the areas of design for lean six sigma, Quality through design, Extreme programming and Systems Engineering.

4. Experience with hardware or software design and development and associated skills relating to QMS, design and developing and testing.

5. Experience with product development and design control from research/concept to product manufacture for at least 3 products, experience with SaMD.

6. Up to date with latest QA/RA requirements i.e. country regulations, standards.

7. Solid knowledge of regulatory standards such as ISO13485, ISO14971, 21 CFR Part 11, IEC 60601, IEC 62304 and AAMI standards applicable to medical devices and software.

8. Ability to own supplier/vendor relations including evaluation and coordination.

9. Demonstrated experience managing a diverse technical team with budgetary responsibility.

10. Possess excellent networking, communication and writing skills.

11. Demonstrate ability to juggle priorities and meet deadlines.

12. Excellent written and verbal communication skills.

13. Enjoy working in a small team, start-up environment.