Senior Device Engineer, Packaging & Medical Devices - 5258

Job content

The Life Science Career NetworkCTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases and other rare diseases.For their Bern (Switzerland) office we are currently looking for a:Senior Engineer Primary Packaging & Medical Devices - 5258for initially 12 months contract with potential extension afterwards.Main Responsibilities

• Maintain knowledge of relevant legislation, regulation, and industry trends in the field of Medical Devices and Combination Products.
• Assure that design verification is performed according to current scientific rational, regulatory /internal guidelines, legal requirements and quality standards. Ensuring data integrity and scientific consistency in all verification testing. Promote data analyses using advanced statistical techniques and communicate results to a cross-functional team.
• Develop and execute Human Factors Engineering plans as per current standards and guidelines (e.g. FDA HFE Guidelines, IEC 62366, EN ISO 14971, AAMI HE75, 21 CFR part 820, etc. )
• Write and review HF study protocols (formative and summative studies
• Ensure R&D efforts related to the development of new products and design modifications to existing products follow the appropriate Design Control procedures as mandated by Health Authorities
• Ensure robust device selection, assessment of container-device compatibility and container-drug compatibility, development of testing methods to assess container and deliver system quality and functionality for existing and new technologies.
• Interface with experts from outside sources, companies, and forums to maintain an understanding of new developments in drug delivery
• Ensuring the team assesses and utilizes the most innovative technical approaches, where feasible, for the device selection, verification and validation
• Support of reports review of final reports, data, questions for regulatory submissions/filings
• Support with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
• Supporting the creation, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
• Compilation and maintenance of Design History File content and Conformity Assessments
• Ensuring agreed targets for quality, timelines, costs, and user requirements are met

Qualifications And Experience

• Relevant working/residency permit or Swiss/EU-Citizenship required;
• 5 + years experience in Pharma Device Development
• Completed technical, commercial training, technician or technical college degree an advantage
• University degree, in a relevant field of science e.g. engineering, in biotechnology / biochemistry / biology or corresponding qualification based on work experience in a relevant field.
• Strong scientific background in all aspects of primary packaging and drug delivery. Must have the education and experience 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 .
• Experience with test method development, Combination Product Verification Testing, and specification generation.
• Highly 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

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