Product Development Engineer

Jobtailor; Thousand Oaks (CA); On-site; USD 95,000 - 125,000; Full time

Job summary

Jobtailor in Thousand Oaks, CA is seeking a qualified Mechanical or Biomedical Engineer to lead New Product Development for surgical implants and medical devices, ensuring ISO 13485 compliance and FDA readiness.

You will plan and execute Design Verification and Validation, conduct FMEA risk management, biocompatibility and sterilization evaluations, review drawings with GD&T, and generate technical documentation to support product launches.

Qualifications

• 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.

Responsibilities

• 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.

Skills

New Product Development

ISO 13485 Compliance

3D CAD Modeling

Technical Writing

Risk Management (FMEA)

Education

Bachelor’s degree in Mechanical Engineering or Biomedical Engineering

Tools

SolidWorks

Engineering Drawings

Job description

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 (SolidWorks or similar).
• Strong technical writing skills and experience writing product requirements, specifications, test protocols and test reports, and engineering rationales.

Core Competencies

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)

Hard Skills

• Finite Element Analysis
• Geometric Dimensioning & Tolerancing (GD&T)
• Design Verification & Validation
• Biocompatibility Evaluation
• Sterilization Evaluation

Soft Skills

• Attention to Detail
• Analytical Thinking

Industry Keywords

• Medical Device
• Regulated Industry
• ISO 14971
• ISO 10993-1
• FDA 21CFR Part 820.30

Tools & Technologies

• SolidWorks
• 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 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.