Design Quality Engineer - Medical Devices, Drive NPD Impact

more-jobs; Le Noirmont; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

Supportive environment

Family-oriented structure

Innovative and fast-growing SME

Learning and professional development

Zusammenfassung

Bien-Air Surgery in Switzerland (Le Noirmont) seeks a Design Quality Engineer to lead design quality activities, support NPD and design changes, and ensure compliance with MDR, FDA/ISO standards. You will collaborate with multiple departments and contribute to robust design documentation.

The role requires a Bachelor’s in engineering, 1–3 years in medical devices QA, knowledge of DMR/DHF, ISO 13485 and EU MDR. Proficiency in French and English preferred; strong organizational skills.

Qualifikationen

• Bachelor's degree in mechanical, micro-mechanical or biomedical engineering.
• 1–3 years’ experience in quality assurance of medical devices, ideally class IIa or above.
• Demonstrated knowledge of DMR and DHF structure and contents.
• Experience with ISO 13485 QMS and with Risk Management for Medical Devices.
• Experience with EU MDR 2017/745.

Aufgaben

• Lead and support New Product Development (NPD) and Design Changes by ensuring compliance of activities and documentation to internal QMS requirements as well as to external regulations and standards (FDA, ISO).
• Support Verification & Validation activities to ensure compliance with applicable Design Control requirements.
• Generate and maintain Risk Management during NPD and Design Changes using principles from ISO 14971.
• Ensure quality assurance according to principles of Design Changes of medical devices during all stages of product development.
• Update existing product documentation in compliance with requirements of MDR.
• Create, review or approve DMR and DHF documentation released during NPD and Design Changes.
• Contribute to generate and maintain User Information Material.
• Contribute to continuous improvement of internal procedures related to NPD, Design Change and Risk Management.
• Become key contributor to product reprocessing methodology and testing (cleaning and sterilization).

Kenntnisse

Quality assurance

Regulatory knowledge

Documentation control

NPD

Design changes

Ausbildung

Bachelor's degree in mechanical, micro-mechanical or biomedical engineering

Tools

MS Office

PLM system

Jobbeschreibung

Bien-Air Surgery in Switzerland (Le Noirmont) seeks a Design Quality Engineer to lead design quality activities, support NPD and design changes, and ensure compliance with MDR, FDA/ISO standards. You will collaborate with multiple departments and contribute to robust design documentation.

The role requires a Bachelor’s in engineering, 1–3 years in medical devices QA, knowledge of DMR/DHF, ISO 13485 and EU MDR. Proficiency in French and English preferred; strong organizational skills.