Job Overview:
A Design Assurance Engineer is required to support the sustainment of commercialized stent platforms and development of new stent platforms.
Key Responsibilities:
* Ensure compliance with quality policy and company systems and procedures in line with Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, MDR 2002 (UK), FDA Quality System Regulations 21 CFR 820, FDA GLP Regulation 21 CFR 58, FDA Labelling Regulation 21 CFR 801, ISO 13485, ISO 14971 and Japanese Ministerial Ordinance # 169.
* Support the development and evolution of Veryan Design Control, Risk Management, and associated systems.
* Provide Design Assurance input to R&D project teams for designated projects.
* Lead risk management activities for assigned projects in line with ISO 14971 and Veryan procedures.
* Develop and maintain design verification and validation plans, protocols, and reports for design changes.
* Support the preparation and delivery of Design Transfer to Commercial Reviews and associated checklists.
* Design, development and validation of test methods as required to support development programs.
* Lead Human Factors / Usability Engineering activities and maintain Usability Engineering File for assigned projects.
* Execute/review gap analysis to standards, ASTMs and other associated documents and assess impact to product DHFs.
* Coaching and mentoring of colleagues and more junior members of the team.
Requirements:
A degree level qualification in Engineering, Science or related field is required.
Upwards of 3 years relevant experience in the medical device industry, preferably with Stent or class III device design assurance experience.
An understanding of ISO 13485, ISO 14971 and FDA QSRs is a prerequisite.
Familiarity with statistics, validation and physical testing is required.
Benefits:
This role offers competitive salary, bonus, hybrid working, full family healthcare, flexible working hours and pension contribution.
The successful candidate will have the opportunity to work as part of a supportive, collaborative team in a state-of-the-art facility.
This is an excellent opportunity to build your career with a rapidly growing medical device company offering a highly differentiated solution in SFA interventions.