Product Development Engineer

Envista Holdings Corporation

Product Development Engineer involved in New Product Development for surgical implants and prosthetics. Collaborating with cross-functional experts and ensuring compliance with industry standards.

Posted 7/29/2026full-timeThousand Oaks • California • 🇺🇸 United StatesJuniorMid-Level💰 $98,700 - $120,700 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in New Product Development for surgical implants and medical devices, ensuring compliance with ISO standards and FDA regulations. Proficient in technical documentation, risk management, and 3D CAD modeling.

Highest-signal resume keywords

New Product DevelopmentISO 13485 Compliance3D CAD ModelingTechnical WritingRisk Management (FMEA)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Finite Element AnalysisGeometric Dimensioning & Tolerancing (GD&T)Design Verification & ValidationBiocompatibility EvaluationSterilization Evaluation

Soft Skills

Attention to DetailAnalytical Thinking

Tools & Technologies

SolidWorksEngineering Drawings

Industry Keywords

Medical DeviceRegulated IndustryISO 14971ISO 10993-1FDA 21CFR Part 820.30

About the role

Key responsibilities & impact

Engage in executing the main elements of New Product Development to introduce surgical implants, prosthetics, and instruments to market.
Participate in planning and execution of Design Verification & Validation activities.
Generate product development documentation ensuring compliance with internal operating procedures, ISO 13485 and FDA 21CFR Part 820.30.
Conduct risk management activities (FMEA) and document results ensuring compliance with internal procedures and ISO-14971.
Conduct biocompatibility and sterilization evaluations and generate documentation ensuring compliance with internal procedures, ISO 10993-1 and ISO 11737.
Perform Finite Element Analysis if needed.
Review dimensions of parts, materials to be used, relations of one part to another, and relation of various parts to whole structure of product lines.
Review and approve drawings, applying knowledge and experience utilizing Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5.

Requirements

What you’ll need

Bachelor’s degree in Mechanical Engineering or Biomedical Engineering
Minimum 2 years’ experience in product development; medical device or another highly regulated industry is highly preferred
Proficient in 3D CAD modeling and Engineering Drawings (SolidWorks or similar).
Strong technical writing skills and experience writing product requirements, specifications, test protocols and test reports, and engineering rationales.

Benefits

Comp & perks

annual performance bonus
medical/dental/vision benefits
401K match