Medical Device Product Development Engineer

Envista Holdings Corporation; Westlake Village (CA); On-site; USD 99,000 - 121,000; Full time

Job summary

Envista Holdings Corporation is seeking a Product Development Engineer to advance new surgical implants, prosthetics, and instruments from concept through design transfer to production. You will work on verification, validation, biocompatibility, sterilization, and cross-functional projects on site in Thousand Oaks, CA.

The role requires a mechanical or biomedical engineering background, 2+ years in regulated product development, and proficiency in 3D CAD and GD&T.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• 2+ years in product development; medical device experience preferred.
• Proficient in 3D CAD and Engineering Drawings (SolidWorks or similar).
• Strong technical writing for requirements, specs, protocols and rationales.

Responsibilities

• Generate development documentation meeting ISO 13485 and FDA 21 CFR 820.30.
• Conduct risk management (FMEA) per ISO 14971 with documentation.
• Perform biocompatibility and sterilization evaluations per ISO 10993-1/11737.
• Carry out Finite Element Analysis when needed.
• Run statistical analysis for test results and sample size rationalization.
• Review parts dimensions, materials, tolerances and GD&T per ASME Y14.5.
• Develop protocols/reports, initiate Change Orders, and document engineering activity.
• Coordinate with vendors to ensure timely action items.

Skills

3D CAD modeling

Engineering Drawings

Technical writing

FMEA

Statistical analysis

GD&T knowledge

Education

Bachelor’s degree in Mechanical Engineering or Biomedical Engineering

Tools

SolidWorks

Finite Element Analysis (FEA)

Job description

Envista Holdings Corporation is seeking a Product Development Engineer to advance new surgical implants, prosthetics, and instruments from concept through design transfer to production. You will work on verification, validation, biocompatibility, sterilization, and cross-functional projects on site in Thousand Oaks, CA.

The role requires a mechanical or biomedical engineering background, 2+ years in regulated product development, and proficiency in 3D CAD and GD&T.