Senior Design Assurance Engineer
Listed on 2026-07-01
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Engineering
Quality Engineering, Regulatory Compliance Specialist, Engineering Design & Technologists, Biomedical Engineer
Senior Design Assurance Engineer
The Senior Design Assurance Engineer is responsible for design quality input and deliverables for new product development programs throughout the product lifecycle. They will also support sustaining activities for investigational and commercial device manufacturing, such as changes, audits, and post-market surveillance ensuring a continuously accurate and compliant Design History File. All engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.
Duties and Responsibilities:
- Project core team member accountable for product development deliverables including, but not limited to:
- Design Controls (plan, inputs/outputs, verification, design review, etc..) per 21 CFR
820.30 - Risk Management (Plan/Report, Hazards Analysis, FMEA/Risk Assessment) per ISO 14971
- Equipment and Material Qualification
- Test Method development and validation
Draft, collaborate, and approve product development deliverables and engineering work orders
Consult and provide guidance on biocompatibility testing per ISO 10993 or collaborate with outside Contract Research Organization
Coordinate and execute, as necessary, testing in support of new product development (e.g. DV, pVal, etc..)
Support the transfer of designs from R&D to manufacturing
Create and maintain up-to-date product Design History Files (DHF)
Advise project teams and lead by example in best-practices for Quality and Regulatory compliance
Proactively identify redundancy and opportunities for efficiency in Quality System requirements
Own, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) are appropriately documented and executed with a lens towards design, risk, and regulatory compliance
Receive, investigate, and document product complaints, interacting with customers as applicable
Support audits as Subject Matter Expert (SME) for QMS processes and product DHFs
Drive Product Lifecycle Management (PLM) architecture and changes, as needed
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