Senior NPI Engineer - MedTech Product Launch

Becton Dickinson NA; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

Becton Dickinson (BD) in Irvine, CA, seeks a Senior Engineer for New Product Introduction to lead transition of medical device products from design to commercial manufacturing.

You will ensure manufacturability, quality, and regulatory compliance while collaborating with R&D, Manufacturing, Quality, and Supply Chain. The role emphasizes DFMs, DFAs, validation (IQ/OQ/PQ), and continuous improvement in a highly regulated environment.

Qualifications

• Bachelor's degree in engineering required; Master's preferred.
• 4+ years in medical device manufacturing or manufacturing process development.
• Experience with DFMs (DFM) and DFAs (DFA); process validation and SPC.

Responsibilities

• Lead all technical aspects of new product introduction from concept to launch.
• Collaborate with R&D, Manufacturing, Quality, and Supply Chain to define processes.
• Participate in DFM/DFA reviews to optimize product designs for manufacturing.
• Develop manufacturing strategies including process flow, tooling design and automation.
• Oversee IQ/OQ/PQ validation for new lines and equipment for regulatory compliance (FDA/ISO 13485).
• Identify and mitigate manufacturing risks early in development; implement preventive actions.
• Drive continuous improvement of NPI processes to reduce costs and time-to-market.
• Coordinate supplier selection and qualification for new products.

Skills

DFM

DFA

Cross-functional

Process validation

SPC

SolidWorks

Creo

Lean manufacturing

Spanish

Project management

Education

Bachelor's degree

Master's degree

Tools

SolidWorks

Creo

Job description

Becton Dickinson (BD) in Irvine, CA, seeks a Senior Engineer for New Product Introduction to lead transition of medical device products from design to commercial manufacturing.

You will ensure manufacturability, quality, and regulatory compliance while collaborating with R&D, Manufacturing, Quality, and Supply Chain. The role emphasizes DFMs, DFAs, validation (IQ/OQ/PQ), and continuous improvement in a highly regulated environment.