Senior NPI Engineer: Medical Device Launch & Manufacturing
RXinsider LTD.
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Job summary
BD in Irvine is seeking a Senior Engineer, New Product Introduction, to lead the transition of new medical device products from design to commercial manufacturing. You will ensure manufacturability, quality, and regulatory compliance while serving as a bridge between R&D, Manufacturing, Quality, and Supply Chain.
You will drive DFx, process validation (IQ/OQ/PQ), risk mitigation, supplier qualification, and continuous improvement across NPI, with opportunities to influence design through
Qualifications
- Bachelor's degree in engineering required; Master's preferred.
- Minimum 4 years in medical device manufacturing or process development.
Responsibilities
- Lead NPI from concept to commercial launch with timelines, budgets and quality.
- Collaborate with R&D, Manufacturing, Quality and Supply Chain to optimize processes.
- Participate in DFM/DFA reviews to improve designs for manufacturability.
- Develop manufacturing strategies, tooling design, and automation solutions.
- Oversee IQ/OQ/PQ validation for new lines and equipment with regulatory compliance.
- Identify and mitigate manufacturing risks early and implement preventive measures.
- Drive continuous improvement and supplier qualification for new products.
Skills
Education
Tools
Job description
BD in Irvine is seeking a Senior Engineer, New Product Introduction, to lead the transition of new medical device products from design to commercial manufacturing. You will ensure manufacturability, quality, and regulatory compliance while serving as a bridge between R&D, Manufacturing, Quality, and Supply Chain.
You will drive DFx, process validation (IQ/OQ/PQ), risk mitigation, supplier qualification, and continuous improvement across NPI, with opportunities to influence design through
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