Senior NPI Engineer, Medical Device Launch

BD; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

The Senior Engineer, New Product Introduction (NPI) at BD will lead the transition of new medical device products from design to commercial manufacturing, ensuring manufacturability, quality, and regulatory compliance across the product lifecycle.

Working closely with R&D, Manufacturing, Quality, and Supply Chain, you will define and optimize processes, validate lines (IQ/OQ/PQ), drive cost and schedule improvements, and coordinate supplier qualification to deliver robust manufacturing

Qualifications

• Bachelor's degree in engineering required; master's preferred.
• Minimum 4 years in medical device manufacturing or process development.
• Experience with DFM/DFA and process validation (IQ/OQ/PQ).
• Strong knowledge of Lean Six Sigma and SPC.
• Ability to work in a regulated, cross-functional environment.

Responsibilities

• Lead NPI from concept through commercial launch with timelines and quality in focus.
• Collaborate with R&D, Manufacturing, Quality and Supply Chain to optimize processes.
• Participate in DFM/DFA reviews and provide feedback to design teams.
• Develop robust manufacturing strategies, including tooling and automation.
• Oversee IQ/OQ/PQ for new lines and equipment; ensure regulatory compliance.
• Drive continuous improvement and supplier qualification for new products.

Skills

DFM

DFA

Manufacturing processes

Process validation

SPC

CAD

GD&T

Six Sigma

Education

Bachelor's degree in engineering

Master's degree preferred

Tools

SolidWorks

Creo

Job description

The Senior Engineer, New Product Introduction (NPI) at BD will lead the transition of new medical device products from design to commercial manufacturing, ensuring manufacturability, quality, and regulatory compliance across the product lifecycle.

Working closely with R&D, Manufacturing, Quality, and Supply Chain, you will define and optimize processes, validate lines (IQ/OQ/PQ), drive cost and schedule improvements, and coordinate supplier qualification to deliver robust manufacturing