* 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
Role overview
This position is in the Biotherapeutics Pharmaceutical Research and Development (Drug Product Design and Development) located in Cambridge, UK. The incumbent will provide design control and risk management subject matter expertise to medical device combination product development programmes throughout the product lifecycle. This will involve ensuring consistent implementation of applicable processes and standards across the portfolio, in addition to the facilitation and documentation of specific design control and risk management activities, whilst interacting with cross functional development teams at all levels of the organisation.
Primary Duties
* 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.
Organizational Relationships
* 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.
Education, Skills And Experience
Either:
* 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
* OR
* 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 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.
Technical Skills Requirements
* 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).
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