Senior Design Assurance Engineer
Posted on Feb 22, 2021 by Real Staffing Group
Job title: Senior Design Assurance Engineer
Location: Ballybrit, Galway
Benefits: Excellent salary, pension, healthcare and yearly bonus.
My clients company culture of innovation helps each individual develop both professionally and personally, and our culture of respect means that we all work in a collaborative, supportive and exciting environment.
Reporting to the Design Assurance Manager the successful candidate will be focused on the development of new stent platforms, working predominantly on projects to introduce or improve products for treatment of a range of peripheral arterial disease states.
- Work within the quality system and ensuring that the quality policy and company systems and procedures are complied with in line with the Medical Device Directive 93/42/EEC
- Support the development/evolution of the Design Control, Risk Management and associated systems, to encompass new product development technologies.
- Provide Design Assurance input to R&D project teams for designated projects
- Understanding the Regulatory requirements for device developments and providing input to projects to encompass these requirements.
- Lead in specification development in relation to design input development. Participate in the generation of Design Input/Output documents.
- Lead the risk management activities for designated projects and design changes.
- Design, development and validation of test methods as required to support development programs.
- Develop and maintain design verification and validation plans, protocols and reports.
- Support R&D in the preparation and delivery of Design Reviews and associated checklists.
- Establish and maintain the Design History File and associated documents.
- Provide QA support to R&D for equipment management
- Execute assigned aspects of the project, as required.
- Mentor and support Design Assurance engineers.
- Ensure assigned areas are in a state of readiness for unannounced and planned audits.
- Act as a design assurance representative during audits of areas of assigned responsibility.
- Bring effective closure to non-conformances highlighted.
Education & Training
A degree level qualification in Engineering, Science or related field is required.
- Upwards of 5 years' relevant experience in the medical device or pharmaceutical industry, preferably with Stent and Stent Coating technology experience.
- An understanding of ISO13485, ISO14971 and FDA QSRs is a prerequisite.
- Familiarity with statistics, validation and physical testing is required.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales