Senior Design Assurance / Quality Engineer

Polytec Personnel Ltd
30 Nov 2017
02 Jan 2018
Contract Type
Full Time
We are looking for a Design Assurance or Quality Engineer experienced in medical products to join a Cambridge based company to contribute to technology development projects and translate regulatory requirements into product requirements ensuring compliance to relevant standards and regulations.


* Take an active role in Design Reviews to assess quality and compliance
* Review requirements for traceability and testability
* Lead product risk management activities according to ISO14971 (including creation of Risk Management Plan, FMECAs, Fault Tree Analysis and Risk Management Report)
* Plan verification programmes, including interpretation and implementation of relevant standards, and establishment of acceptance criteria
* Perform analysis and interpretation of test data, including statistical analysis where necessary
* Help clients optimise their medical development processes
* Supporting creation of Technical Files / Design History Files
* Including review of client's Technical File / DHF
* Perform gap analysis against quality system and regulatory requirements
* Creation of essential requirements checklists


* A good degree in Engineering or related technical discipline
* Experience of working in multi-disciplinary teams
* Significant experience of risk management with regard to Medical Product development (according to ISO14971)
* Excellent understanding of medical device directive 93/42/EEC, ISO13485 and FDA QSR
* Experience of Design Verification
* Excellent communication skills
* Ability to review the work of others

The following would be advantageous:

* Knowledge and experience of implementing IEC 60601 and / or IEC 62304
* Experience of liaising with the US FDA with regards to device submissions
* Experience of Design Validation
* Experience of design and development of, and regulatory submission for combination products / borderline products
* Experience of regulatory requirements regarding testing of pharmaceuticals
* Experience of manufacturing line qualification processes
* Experience of other applicable European directives including the in vitro diagnostic directive (98/79/EC), active implantable directive (90/385/EEC) and medicinal product directive (2001/83/EC)

This job was originally posted as