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:

o Design Controls (plan, inputs/outputs, verification, design review, etc..) per 21 CFR820.30

o Risk Management (Plan/Report, Hazards Analysis, FMEA/Risk Assessment) per ISO 14971

o Equipment and Material Qualific...