Senior Design Engineer

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

Senior Design Engineer – Spine Implants & Surgical Instruments

Our client is looking for an experienced Senior Design Engineer to join an innovative Swiss medical-device company developing advanced technologies for spinal surgery.

In this role, you will be responsible for the design of spinal implants and surgical instruments, working at the intersection of mechanical engineering, medical technology and clinical application.

This is an opportunity to join a highly collaborative R&D environment where you can take products from early-stage concepts through prototyping, verification and validation to clinical use.

You will play a key role in translating clinical and technical requirements into safe, innovative and manufacturable medical devices.

Your responsibilities will include:

• 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

What we're looking for

• 5+ years of experience in medical-device product development
• Strong experience with orthopedic, spinal, surgical or implantable devices is preferred
• Experience developing surgical instruments and/or implants
• Excellent 3D CAD skills; experience with Siemens NX is highly desirable
• The ability to work independently while contributing effectively to a multidisciplinary team
• Very good written and spoken German and/or English