Design Control Engineer

CK Group; Cambridge; On-site; GBP 80,000 - 100,000; Full time

Job summary

A prestigious company in the biopharmaceutical sector is seeking a Design Control Engineer for a 12-month contract in Cambridge. The role involves overseeing design control activities and ensuring compliance with regulatory standards for medical devices, contributing to groundbreaking healthcare solutions.

Qualifications

• Hold a relevant scientific degree or equivalent experience.
• Working knowledge of ISO standards and EU Medical Devices Regulation.
• Experience in design control and risk management for medical device combination products.

Responsibilities

• Lead design control and risk management activities for medical device products.
• Ensure compliance with quality and regulatory standards.
• Support the generation of regulatory submission data.

Skills

Design control

Risk management

ISO 9001

ISO 13485

Human Factors Engineering

Education

Relevant scientific degree or equivalent experience

Job description

CK Group are recruiting for a Design Control Engineer, to join a company in the pharmaceutical industry, on a contract basis for 12 months.


Salary:

From £16.76 to £20.79 per hourPAYE or £18.78 to £23.30 per hourUMB.


Design Control Engineer Role:

• Lead design control and risk management activities for medical device combination product development programmes.
• Support and facilitation of effective design control and risk management activities internally, at external design companies, and at the clients manufacturing facilities/CMOs.
• 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.

Your Background:

• Hold a relevant scientific degree or have equivalent working experience.
• Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
• Experience in design control and risk management for medical device combination products and/or medical devices.
• Familiar with Human Factors Engineering - Usability Engineering.
• Familiar with device assembling manufacturing processes.

Company:

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.


Location:

This role is based at our clients site in Cambridge.


Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 141 245 in all correspondence.


Please note:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.

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