Senior Design Assurance Engineer

Job Description:

Position Responsibilities:

In this role, you will support product development activities to enable a successful production launch and sustained delivery of high-quality products, while partnering with Engineering, Operations, Quality, Marketing, and Regulatory to execute design control, documentation, and compliance deliverables. Execute and support completion of product development deliverables across the design lifecycle Create and maintain Design History File documentation to ensure completeness, accuracy, and regulatory compliance Support development and maintenance of customer requirements, product requirements, and product specifications Lead and support completion and maintenance of product risk management deliverables through cross-functional collaboration Author design verification and design validation plans and reports Implement sampling inspection approaches and support qualification activities for purchased components Support design test method development and lead test method validation activities Apply statistical techniques to support characterization, verification, and validation testing and root cause analysis Support quality system deliverables, including nonconformances and CAPAs Perform other related duties and responsibilities, as assigned Position requirements: BS in Engineering or related technical discipline 5 years of experience in Engineering or Quality within the medical device industry Strong working knowledge of design controls and DHF documentation practices Experience authoring and executing verification and validation plans, protocols, and reports Experience supporting or leading risk management activities aligned to

ISO 14971

Experience with test method development and validation Proficiency with quality systems fundamentals and good documentation practices Experience investigating nonconformances and implementing CAPA Working knowledge of

FDA 21 CFR, EU

MDR, Australian TGA, and

ISO 13485

Strong written and verbal communication skills with cross-functional collaboration capability Ability to work independently with limited supervision Reasons to

Apply:

Competitive salary plus a comprehensive benefits package. Health coverage, retirement plans, and other company-sponsored perks. Generous paid time off, including holidays, to support work-life balance. Flexible schedules and work life balance. Strong focus on employee development with on-the-job training and career growth. A positive company culture that values diversity and collaboration.