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Product Development Engineer
Job in
Thousand Oaks, Ventura County, California, 91362, USA
Listed on 2026-08-17
Listing for:
Jobtailor
Full Time
position Listed on 2026-08-17
Job specializations:
-
Engineering
Quality Engineering, Product Engineer, Engineering Design & Technologists, Biomedical Engineer
Job Description & How to Apply Below
Requirements
- 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 (Solid Works or similar).
- Strong technical writing skills and experience writing product requirements, specifications, test protocols and test reports, and engineering rationales.
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 Development
- ISO 13485 Compliance
- 3D CAD Modeling
- Technical Writing
- Risk Management (FMEA)
- Finite Element Analysis
- Geometric Dimensioning & Tolerancing (GD&T)
- Design Verification & Validation
- Biocompatibility Evaluation
- Sterilization Evaluation
- Attention to Detail
- Analytical Thinking
- Medical Device
- Regulated Industry
- ISO 14971
- ISO 10993-1
- FDA 21
CFR Part 820.30
- Solid Works
- Engineering Drawings
- 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 21
CFR 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.
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