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Senior Product Development Engineer – Shoulders

enovis · Texas

Senior 🇬🇧 English
SolidWorks Risk assessment Verification Validation Design review

Job description

About the role

Enovis is seeking a Senior Product Development Engineer to lead the design and development of surgical instruments and implants for total shoulder arthroplasty. You will work within a cross‑functional team to translate surgeon requirements into innovative, compliant medical devices.

Key responsibilities

  • Participate as an active member of the New Product Development team for shoulder devices.
  • Identify and incorporate surgeon design requirements and product characteristics.
  • Collaborate with manufacturing, purchasing, regulatory, quality, and other engineering functions.
  • Create product designs and supporting documentation, including risk assessments, verification/validation activities, and design review records.
  • Develop 3‑D concepts and mechanisms using SolidWorks.
  • Compile Design Dossiers and Design History Files.
  • Ensure compliance with FDA, ISO, and internal procedures throughout the development cycle.

Required profile

  • Experience in product development for surgical instruments and implants used in total shoulder arthroplasty.

Required skills

  • SolidWorks (3‑D modeling)
  • Risk assessment documentation
  • Verification and validation activities
  • Design review documentation
  • Design Dossiers / Design History Files
  • FDA and ISO regulatory compliance

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Source : ats:workday

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Published 3 months ago

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enovis

Texas