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