Senior Design Engineer - Spine Implants & Surgical Tools

Barrington James; Sankt Gallen; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Barrington James is representing a Swiss medical-device company seeking a Senior Design Engineer to lead the design of spinal implants and surgical instruments from concept to clinical application. The role involves translating clinical requirements into engineering solutions within a multidisciplinary team and a highly regulated environment.

Responsibilities include CAD development, prototyping, V&V planning, and preparing documentation for regulatory submissions in compliance with FDA and

Qualifikationen

• 5+ years of experience in medical-device product development.
• Experience with orthopedic, spinal, surgical or implantable devices.
• Experience developing surgical instruments and/or implants.
• Excellent 3D CAD skills; Siemens NX is highly desirable.
• Ability to work independently within a multidisciplinary team.
• German and/or English language skills.

Aufgaben

• Lead the design and development of spinal implants and surgical instruments from concept through clinical application
• Translate clinical requirements and user feedback into practical engineering solutions
• Create and develop 3D CAD models, assemblies and detailed manufacturing drawings
• Develop prototypes and use rapid prototyping to test and refine concepts
• Plan, coordinate and document design verification and validation (V&V)
• Prepare technical documentation including specifications, risk assessments, test plans and test reports
• Contribute to Design History Files and regulatory submissions
• Work within applicable medical-device design controls and regulatory requirements, including FDA and CE/MDR

Kenntnisse

Medical-device dev

Orthopedic/Spinal implants

Surgical instruments

3D CAD (Siemens NX)

Team collaboration

German/English

Tools

Siemens NX

Jobbeschreibung

Barrington James is representing a Swiss medical-device company seeking a Senior Design Engineer to lead the design of spinal implants and surgical instruments from concept to clinical application. The role involves translating clinical requirements into engineering solutions within a multidisciplinary team and a highly regulated environment.

Responsibilities include CAD development, prototyping, V&V planning, and preparing documentation for regulatory submissions in compliance with FDA and