Senior NPI Engineer - Medical Devices

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

Job summary

BD in Irvine, CA is seeking a Senior Engineer, New Product Introduction (NPI) to lead the transition of new medical devices from design to manufacturing, ensuring manufacturability, quality and timelines.

This role collaborates with R&D, Manufacturing, Quality and Supply Chain; involvement in DFM/DFA reviews, process validation and continuous improvement; requires 4+ years in medical device manufacturing.

BD offers a fast-paced, regulated environment with competitive compensation and benefits.

Qualifications

• Bachelor’s degree in engineering is required, Master’s preferred.
• 4+ years of experience in medical device manufacturing or manufacturing process development.

Responsibilities

• Lead and manage all technical aspects of new product introduction, from concept through commercial launch, ensuring timelines, budgets, and quality.
• Collaborate with R&D, Manufacturing, Quality, and Supply Chain to define and optimize processes, equipment and workflows.
• Participate in DFM/DFA reviews to optimize product designs for manufacturability.
• Develop and implement manufacturing strategies including process flow, equipment selection and automation.
• Oversee IQ, OQ, PQ validations for new lines and equipment ensuring regulatory compliance (FDA, ISO 13485).
• Identify and mitigate manufacturing risks early and implement solutions.
• Drive continuous improvement of NPI processes, reducing costs and time-to-market.
• Coordinate supplier selection and qualification for new products.

Skills

DFM

DFA

Injection molding

Assembly

Sterilization

Automation

Process validation (IQ/OQ/PQ)

SPC

Cross-functional leadership

Communication

Problem solving

Spanish language (preferred)

Lean Manufacturing

Six Sigma

Lead technical projects

Regulatory awareness (FDA/ISO 13485)

Education

Bachelor’s degree in engineering (Mechanical, Electromechanical, Biomedical, Industrial, or related field)

Master’s degree preferred

Tools

SolidWorks

Creo

Job description

BD in Irvine, CA is seeking a Senior Engineer, New Product Introduction (NPI) to lead the transition of new medical devices from design to manufacturing, ensuring manufacturability, quality and timelines.

This role collaborates with R&D, Manufacturing, Quality and Supply Chain; involvement in DFM/DFA reviews, process validation and continuous improvement; requires 4+ years in medical device manufacturing.

BD offers a fast-paced, regulated environment with competitive compensation and benefits.