BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.
The Design Verification & Validation department supports R&D, Production, and Regulatory Affairs in (Productdevelopment-) Projects and manages the verification and validation of design, components, and test methods. The support includes knowledge transfer, active collaboration and reviews.
Your responsibilities
- Planning, execution/ coordination and documentation of design verification & validation activities within development projects, re-certification projects and product maintenance
- Preparation of the DVV strategy and high-level design verification & validation plans and assessments
- Review of the associated documentation within the scope of development projects and product maintenance
- Support of the technical departments in the context of authority queries and audits on the subject of design verification & validation
- Technical support/ advice of the interfaces in connection with design verification & validation activties
- Ensure compliance with internal requirements (SOPs, WIs, etc.) and external requirements (laws,standards, etc.)
- Contribute to the development/optimization and maintenance of the Design Verification & Validation processes and documentation at Biotronik VI
- Development and deployment of competencies in the area of Design Control & Risk Management
- Partecipation in interdepartmental expert groups in the field of Design Verification & Validation
Your Profile
- Completed studies in a technical or scientific field with professional experience
- Several years of relevant professional experience, ideally in the field of DVV
- Product knowledge in the field of medical devices, vascular intervention and combination products is an advantage
- Knwoledge of international regulatory requirements in the area of test method validations (including MDR, FDA/QSR, ISO 13485, ISO 14971, IEC 62366, cGxP)
- Confident application of design verification/validation testing methodology/toos
- Experience in defining, organizing and leading domain related work packages
- Very good written and spoken German and English skills
- Team oriented, accurate and self-dependent personality with an analytical working style
We offer
- Flexible working hours and home office
- At least 25 days of holidays
- Friday after Ascension is a paid absence day
- Training and further development opportunities
- Corporate Benefits e.g., discount for electronic devices, fitness clubs
- Company canteen
- Discounts for public transportation
Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.
Location: Bülach | Working hours: Full-time | Type of contract: Unlimited
Apply now under: www.biotronik.com/careers
Job ID: 59174 | Contact: Martina Micciulla | Tel. + 41 75 429 56 23
