Design Assurance Engineer (experienced in multidisciplinary V&V)
Posted Jun 21 · 0 applicants
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The role in plain words
This role involves leading quality elements of Design Controls and product Design History Files (DHF) for medical devices. You will work closely with R&D and test teams to review user requirements, product specifications, and verification and validation studies. Additionally, you will support regulatory submissions and assist in transferring new products to manufacturing and operations quality teams.
- At least 2-3 years of experience working in a quality function
- Bachelor of Science in Engineering, Sciences, or a related field
- Familiar with statistical techniques used in verification and validation processes
- Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards
- Strong analytical and problem-solving skills, with keen attention to detail
- At least 1 year of experience as a design control engineer
Extracted from the job description · kept up to date automatically
Who this suits
This role suits candidates with a Bachelor of Science in Engineering or Sciences who have at least 2-3 years of quality experience in the medical device industry and familiarity with medical device standards like ISO 13485 and ISO 14971. It is less ideal for those without experience in medical device quality functions or statistical techniques used in verification and validation.
Full job description
Original listing · kept for referenceA medical device company is seeking to hire a Quality Design Assurance Engineer to join our QA team. As a Design Assurance Engineer, you will lead all quality elements of Design Controls and product DHF for new product introductions and sustaining/design projects.
Responsibilities
Quality responsibility to verify that the design and development process follows the procedures and design and development plans.
Work closely with R&D and test teams to support regulatory requirements by creating, reviewing, and providing quality and compliance input to the design and development process, deliverables, and requirements.
Participation in project meetings to review and help update clear and concise user requirements, product specifications, plans, verification and validation studies, risk management files, and other relevant design control deliverables.
Quality responsibility for transferring new products and sustaining projects to manufacturing and operations quality and supplier quality teams.
Support the Regulatory Affairs department for submissions and respond to submission questions, implementation of new or revised standards and support internal and external audits.
דרישות
At least 2-3 years of experience working in a quality function in the medical device industry – must.
At least 1 year of experience as a design control engineer (preferred).
Prior hands-on experience in Verification & Validation (V&V) activities within the medical device industry – a significant advantage.
A Bachelor of Science in Engineering, Sciences, or a related field – must.
Familiar with statistical techniques used in verification and validation processes – must.
Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards – must.
Strong analytical and problem-solving skills, with keen attention to detail.
Excellent communication and interpersonal skills
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Questions about this role
- This listing did not state a salary. We only show pay when the employer publishes it.
- At least 2-3 years of experience working in a quality function, Bachelor of Science in Engineering, Sciences, or a related field, Familiar with statistical techniques used in verification and validation processes, Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards, Strong analytical and problem-solving skills, with keen attention to detail