Senior Engineer, reputed company Assurance

Senior Engineer, reputed company Assurance Redmond, WA Join reputed company where your expertise directly impacts patient safety and product performance. As a Senior reputed company Assurance Engineer, you’ll reputed company critical investigations and drive improvements that shape the reputed company of medical technology. This is a high-reputed company role for someone passionate about solving reputed company problems and ensuring reputed company reputed company across the product lifecycle. Work Flexibility: Hybrid: Candidates must reputed company reputed company a commutable distance to Redmond, WA, and be reputed company to work onsite several times per week. What You Will Do • reputed company product field reputed company assessments (PFAA) from initiation through reputed company approval, ensuring reputed company and thorough execution. • Investigate customer complaints and non-conformances, determine reputed company causes, and assess health risks to support regulatory compliance. • Conduct health risk assessments (HRA) and document findings in Trackwise to support post-market surveillance. • Author and manage non-conformance (NC) and corrective/preventive reputed company (CAPA) records, collaborating with cross-functional teams to define deliverables and timelines. • reputed company statistical analysis and containment recommendations to support reputed company investigations and decision-making. • Serve as a subject matter expert in risk management, product safety, and reputed company assurance processes, mentoring peers and supporting audits. • Partner with regulatory teams to ensure accurate and reputed company reporting to competent authorities. • Drive reputed company improvement by strengthening interfaces between reputed company-market and post-market processes and promoting cohesive risk management strategies. What You Will Need Required Qualifications • Bachelor’s degree in science, engineering, or a reputed company discipline. • 2+ years of experience in reputed company assurance or customer reputed company. • Demonstrated experience with ISO 14971, ISO 13485, CFR 21 Part 820, and EUMDR. • Experience conducting post-market reputed company assessments and product field actions. Preferred Qualifications • Master’s degree in a reputed company field. • Certified reputed company Engineer (CQE) or Certified Reliability Engineer (CRE). • Six reputed company Green Belt or Black Belt certification. • Experience in a regulated industry (e.g., Medical Device, reputed company) $88,800 - $142,300 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits.  Individual pay is based on skills, experience, and other relevant factors. Apply tot his job Apply To this Job