Combination Product Device Development Engineerjob

vor 2 Monaten

Bern, Schweiz Consultys Vollzeit

Missions 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) 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 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. Application of knowledge pertaining to 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, compilation (and maintenance) of Design History Files, verification and validation and clinical trial/commercial manufacture support. Present at internal and external scientific conferences to build awareness of the Groups skills and experience in the drug delivery.
- Contribute to the Company culture of being collaborative, respectful, transparent, ethical, efficient, high achieving, and fun

Profil At least 5 years’ experience in Pharma Device Development 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. Proven ability to work closely and efficiently with employees and colleagues of all levels as well as proven ability to be independent and self-motivated, demonstrating strong organizational and communication skills. 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. Knowledge of Stability Studies, Compatibility studies and long-term functionality testing Ignite Agility - Instills personal flexibility in self and teams. Shows openness to learning and the flexibility to adjust to new situations. Expands and builds capabilities to meet evolving business needs and helps others do the same.
- Flexible work hours and options are available; however, the position is expected to have Bern on-site visibility at a minimum of 60%.

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