Design Quality Engineer/V&V

This role will be responsible for design quality engineering activities that span the product development process and design transfer to manufacturing.

Included in the role is the responsibility to develop risk management documentation, and use risk management to address product design and process changes, product and process quality issues, and compliance issues. This person will partner with Research & Development to facilitate the design control process and will partner with operations for process improvement and continuous improvement initiatives.

Requirements:

BSc Science/Engineering degree or higher

At least 5 years prior experience related to design quality in a medical device company

Working knowledge of the FDA Quality System Regulation 21CFR 820, 21CFR Part11, ISO13485, ISO14971 and the Medical Device Directive MDD/MDR.

Experience in risk evaluation techniques, e.g. FMEA, fault tree analysis.

Working knowledge of software and electrical medical devices related standards, IEC62304, IEC 60601, usability and human factors standards

Demonstrated scientific analysis abilities

Bachelors degree required