(Senior) Device Engineer Primary Packaging and Medical Devices (f/m/d) - 100%

For a worldwide leading biotherapeutics company in Bern we are looking for a

The Primary Packaging & Medical Device Development organisation is focused on the design, development, commercialization and maintenance of a diverse portfolio of drug delivery technology solutions to enable delivery of innovative therapies.

The (Senior) Device Engineer of the Primary Packaging and Medical Devices team is responsible for the selection, evaluation, improvement, verification, implementation and maintenance of new and existing primary packaging materials and medical devices.

Tasks and responsibilities

• Selection, evaluation, improvement, qualification, implementation of new and existing primary packaging materials, medical devices, and Combination Products
• Provide scientific support to maintain the design of our existing commercially released Combination Products. Coordinate cross-functionally with Regulatory, Quality Assurance, Production, Manufacturing, and Supply Chain to provide post launch support, including design and supplier-related changes, product complaints, root cause analysis and other compliance projects
• Execute projects within the agreed time, quality and cost constraints, resulting in state-of–the-art drug delivery devices. Develop high-level plans, schedules, resource estimates, and budgets for projects
• Apply knowledge of the regulatory landscape to ensure standard compliant designs, working to Quality Management Systems such as ISO 13485, and 21CFR820 Design Control, risk management to ISO14971, EU MDR requirements
• Establish and manage key company relationships with suppliers, CRO’s, CMO’s and standardizing Committees

Your profile

• University degree in a relevant field of science (e.g. Engineering, Biotechnology, Biochemistry, Biology) or corresponding qualification based on work experience in a relevant field
• 3+ years’ experience in Pharma Device Development
• Strong scientific background in all aspects of primary packaging and drug delivery to understand and comply with Worldwide Combination Product & Medical Device Regulations
• Experience with regulatory and quality standards and generation of documentation to support quality assessments and for submission to regulatory agencies
• Experienced in working to Quality Management Systems such as ISO 13485, and 21CFR820 Design Control, risk management to ISO14971, EU MDR requirements, compilation (and maintenance) of Design History Files, verification and validation and clinical trial/commercial manufacture support

General information

• Start date: asap
• Duration of employment: initially planned for 12 months
• Place of work: Bern (on-site at a minimum of 60%)
• Workload: 100 %

Your application

If you are interested in this opportunity, please send your CV in English.