Medical Device Product Development Engineer - Implants

Envista Holdings Corporation; Thousand Oaks (CA); On-site; USD 98,700 - 120,700; Full time

Job summary

Envista Holdings Corporation seeks a Product Development Engineer to drive New Product Development for surgical implants, prosthetics, and instruments. You will contribute to concept development, design, verification, validation, and transfer to production, collaborating with cross-functional teams.

On-site in Thousand Oaks, you will generate documentation, conduct risk assessments (FMEA), and perform biocompatibility and sterilization evaluations while ensuring ISO 13485 and FDA 21 CFR 820.30

Qualifications

• Bachelor’s degree in Mechanical Engineering or Biomedical Engineering.
• Minimum 2 years’ experience in product development in a regulated industry.
• Proficient in 3D CAD modelling and engineering drawings (SolidWorks or similar).
• Strong technical writing skills for requirements, specs, test protocols and reports.

Responsibilities

• Execute key elements of New Product Development for surgical implants and devices.
• Support concept development, design, verification/validation, and transfer to production.
• Create and review engineering documentation and participate in design reviews.
• Coordinate with cross-functional teams on project activities and timelines.

Skills

Technical writing

Quality systems

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

GD&T

FMEA

Statistical analysis

Job description

Envista Holdings Corporation seeks a Product Development Engineer to drive New Product Development for surgical implants, prosthetics, and instruments. You will contribute to concept development, design, verification, validation, and transfer to production, collaborating with cross-functional teams.

On-site in Thousand Oaks, you will generate documentation, conduct risk assessments (FMEA), and perform biocompatibility and sterilization evaluations while ensuring ISO 13485 and FDA 21 CFR 820.30