Lead Mechanical Process Development Engineer - Med Devices

MiniMed; Los Angeles (CA); Hybrid; USD 109,000 - 185,000; Full time

Job summary

MiniMed seeks a Principal Mechanical Process Development Engineer to lead development for insulin pumps, glucose sensors, and accessories. You will drive process development, validation, design transfer, and scalable manufacturing readiness, leveraging Six Sigma and DOE to enable robust product designs.

The role requires extensive experience in NPI, IQ/OQ/PQ, and DRR/GR&R, with cross-functional collaboration across Design, NPI, Manufacturing, Quality, and Regulatory teams.

Qualifications

• Bachelor of Engineering with 7+ years in mechanical product and process development; or Master with 5+ years.
• Experience in new product introduction and process development.
• Experience with IQ/OQ/PQ, TMV, and design transfer to manufacturing.

Responsibilities

• Lead product and process development activities for electromechanical medical products.
• Drive design transfer to manufacturing.
• Apply DRM, DFSS, DFM/A during design and development phases.
• Lead process characterization, design characterization testing, and TMV.
• Assist with equipment selection, tooling design, procurement, installation, and qualification.
• Demonstrate proficiency with CAD; SolidWorks, GD&T, tolerance analysis.
• Apply risk management (dfMEA, pfMEA, hazard analysis).
• Collaborate with manufacturing to ensure high-volume feasibility early in development.
• Work with suppliers to ensure components meet design requirements and diagnose issues.
• Present findings and project status to cross-functional teams and management.

Skills

Six Sigma

DOE

Statistical analysis

Design for DFSS

GR&R

Education

Bachelor of Engineering

Master of Engineering

Tools

SolidWorks

GD&T

Job description

MiniMed seeks a Principal Mechanical Process Development Engineer to lead development for insulin pumps, glucose sensors, and accessories. You will drive process development, validation, design transfer, and scalable manufacturing readiness, leveraging Six Sigma and DOE to enable robust product designs.

The role requires extensive experience in NPI, IQ/OQ/PQ, and DRR/GR&R, with cross-functional collaboration across Design, NPI, Manufacturing, Quality, and Regulatory teams.