Senior Design Engineer - Switzerland

Barrington James; Sankt Gallen; Vor Ort; CHF 90.000 - 140.000; Vollzeit

Zusammenfassung

Barrington James in Switzerland is seeking a Senior Design Engineer to lead the design and development of surgical instruments and implants from concept through clinical application, while complying with strict regulatory requirements.

You will work with multidisciplinary teams to create CAD models, perform V&V, manage risk, and prepare DHF documentation, translating clinical needs into market-ready medical device solutions.

Qualifikationen

• 5+ years in orthopaedic instrument or implant development.
• Degree in Mechanical/Medical Engineering or related field.
• Proficient in CAD, preferably Siemens NX, in regulated medical devices.

Aufgaben

• Lead the design and development of medical devices from concept through to clinical application.
• Develop detailed CAD models, prototypes and technical designs.
• Perform tolerance analysis, risk analysis and design assessments.
• Use rapid prototyping and creative problem-solving techniques to develop innovative solutions.
• Plan, execute and document Design Verification & Validation (V&V) activities.
• Prepare and maintain technical documentation, including risk analyses, test reports and specifications.
• Support the creation and maintenance of the Design History File (DHF).
• Work closely with multidisciplinary teams, including engineering, quality, regulatory and clinical stakeholders.
• Translate clinical needs into practical, market-ready medical device solutions.

Kenntnisse

Orthopaedic instrument design

CAD modelling

Siemens NX

Regulated medical device experience

Risk management

Documentation & V&V

Cross-functional collaboration

English/German communication

Ausbildung

Mechanical/Medical Engineering degree

Tools

DHF knowledge

CAD software literacy

Jobbeschreibung

Senior Design Engineer | Medical Devices | Switzerland |

The Role

You’ll be responsible for the design and development of surgical instruments and implants, taking products from early concept through to clinical application while working within strict regulatory requirements.

Key Responsibilities

• Lead the design and development of medical devices from concept through to clinical application
• Develop detailed CAD models, prototypes and technical designs
• Perform tolerance analysis, risk analysis and design assessments
• Use rapid prototyping and creative problem‑solving techniques to develop innovative solutions
• Plan, execute and document Design Verification & Validation (V&V) activities
• Prepare and maintain technical documentation, including risk analyses, test reports and specifications
• Support the creation and maintenance of the Design History File (DHF)
• Work closely with multidisciplinary teams, including engineering, quality, regulatory and clinical stakeholders
• Translate clinical needs into practical, market‑ready medical device solutions

What We’re Looking For

• 5+ years’ experience in the development of orthopaedic instruments and/or implants
• Degree or equivalent qualification in Mechanical Engineering, Medical Engineering or a related discipline
• Strong CAD experience – ideally Siemens NX
• Experience designing products within a regulated medical device environment
• Knowledge of FDA, CE/MDR and medical device regulatory requirements
• Experience with technical documentation, verification/validation and risk management
• Creative, hands‑on approach to engineering and product development
• Strong problem‑solving skills and the ability to turn clinical requirements into engineering solutions
• Excellent German and/or English communication skills
• Comfortable working as part of a multidisciplinary, collaborative team