Design Control and Risk Management Compliance Engineer
- Cambridge
- £20.79 per hour
- Temporary
- Full-time
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- Job Title: Design Control and Risk Management Compliance Engineer
- Contract: 12 months
- Hours:37 hrs p/w
- Location: Cambridge
- Pay rate: up to £20.79 p/h DOE
- Lead design control and risk management activities for medical device combination product development programmes, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
- Support and facilitation of effective design control and risk management activities internally, at external design companies, and at the business manufacturing facilities/CMOs related to assigned projects.
- Generation, approval, and retention of business' design control and risk management documentation ensuring that quality and regulatory requirements are satisfied.
- Ensure medical device combination product design control and risk management activities are compliant with quality and regulatory standards, both internal and external.
- Provide input and support to design validation including, but not limited to, use-related risk assessments.
- Support the generation of all regulatory submission data and content for assigned medical device combination product projects.
- Support internal and external audits of the Biotherapeutics Pharmaceutical Research and Development Quality Management Systems.
- Device development teams - Drug Product leads, packaging engineers, medical device combination product engineers, device development leads, human factors SMEs, design engineers and device analytical scientists.
- Co-development team - drug product and device SMEs.
- Quality Assurance
- GCMC (Regulatory)
- PGS - manufacturing sites and post launch device team.
- External designers and contract manufacturing organizations.
- BSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 5 years of relevant experience in the pharmaceutical combination product and/or device industries
- MSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 5 years of relevant experience in the pharmaceutical combination product and/or device industries
- History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Experience in design control for medical device combination products and/or medical devices
- Experience in risk management for medical device combination products and/or medical devices.
- Familiar with Human Factors Engineering - Usability Engineering.
- Familiar with device assembling manufacturing processes.
- Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Familiarity EN 62366, EN 60601, and EN 62304.
- Able to learn and apply established procedures in a reliable and consistent manner.
- Capable of working independently with minimal supervision.
- High level of attention to technical details and accuracy.
- Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.
- Able to work collaboratively in cross functional teams.
- Excellent communication (e.g., oral, written, presentation) and interpersonal relationship skills.
- Proficiency in general computer software such as word processing, spreadsheets, presentations.
- Understand Good Manufacturing Practices (GMP).