Device Compliance Engineer

Job Title - Device Compliance Engineer

Location - Cambridge

Contract - 12 months

Working pattern - Hybrid

Pay - PAYE - -16.77 p/h up to -25.98 p/h, Umbrella - -18.79 p/h up to -29.12 p/h

SRG are working with a global leading pharmaceutical company that are seeking a Device Compliance Engineer to join their busy team.

Key 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.

Basic Qualifications:

• BSc, MSc or PhD 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 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.
• Thorough working knowledge of ISO 9001, 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.
• Able to learn and apply established procedures in a reliable and consistent manner.
• Capable of working independently with minimal supervision.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.