Seeking a highly experienced Senior Project Engineer to lead and support complex New Product Development (NPD) and process development initiatives in collaboration with R&D and Manufacturing teams. This role will be instrumental in developing and implementing robust, scalable manufacturing processes and supporting the full lifecycle of medical device products - from concept and design through to commercialization.
Key Responsibilities
- Serve as the technical lead on NPD projects, partnering with R&D to ensure new designs are manufacturable and scalable for production.
- Lead the development of robust, high-yielding manufacturing processes for new products in alignment with quality and regulatory standards.
- Drive design for manufacturability (DFM) activities, providing proactive input into product design to optimize for efficient production.
- Collaborate cross-functionally to plan, execute, and deliver process development activities in line with NPI timelines and quality targets.
- Engage with equipment vendors for custom automation and tooling solutions, managing these from concept through to onsite implementation.
- Author and execute IQ/OQ/PQ protocols for new processes and equipment associated with NPD programs.
- Ensure smooth transfer of validated manufacturing processes to the production floor, including operator training and documentation support.
- Identify and implement continuous improvements to support product quality, efficiency, and cost reduction.
- Lead cross-functional technical discussions and act as an SME in process development and NPD engineering strategy.
Qualifications & Experience
- Bachelor's degree (Level 8) in Engineering or a related technical discipline (e.g., Mechanical, Manufacturing, Production, Electronic).
- 8-10 years of experience in process or manufacturing engineering within the medical device industry, with a strong focus on new product development (NPD).
- Demonstrated leadership in end-to-end NPD projects, from concept through process validation and production ramp-up.
- Strong track record in process development, validation, and equipment qualification.
- Experience working in cross-functional teams with R&D, QA/RA, and Operations.
- Excellent problem-solving and analytical skills, with proven application of tools such as DOE, DMAIC, or Six Sigma.
- Skilled communicator with the ability to influence and lead technical teams and external partners.
- Hands-on experience in at least one of the following areas is required:
- Injection Moulding
- Process Characterization
- Equipment Validation
- Design for Manufacturability (DFM)
- NPI/NPD in regulated manufacturing environments