Device Engineer

Please find below details about the role:

Job Title: Device Compliance Engineer/Quality Engineer

Contract Duration: 12 months

Location: Cambridge

Working Environment: Hybrid (2.5 days p/w onsite)

Position Summary:

This position is in the Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence located in Cambridge, UK. The incumbent will provide design control and risk management subject matter expertise to medical device and combination product development programmes throughout the product lifecycle. This will involve generation and review of design history file and risk management file components whilst interacting with cross functional development teams at all levels of the organisation.

Responsibilities:

• Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
• Support and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
• Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
• Provide input and support to design validation including, but not limited to, human factors engineering assessments.
• Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply.
• Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
• Support the generation of all regulatory submission data and content for assigned device projects.
• Support internal and external audits of the DCoE Quality Management System.
• Identify, communicate, and develop strategies to improve combination product systems.

Education, Skills and Experience:

• 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.
• 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.
• Working knowledge of EN 62366, EN 60601, and EN 62304.
• Experience in design controls for combination products.
• Device risk management expertise.
• Familiar with Human Factors Engineering - Usability Engineering.
• Understand project management methodologies and capable to provide technical leadership for projects.
• Familiar with device assembling manufacturing processes.
• Ability to perform to perform complex data analysis.
• Understand Good Manufacturing Practices (GMP).