Senior Design Quality Engineer

Experteer Overview In this role you ensure design quality across the product lifecycle for Sleep & Respiratory Care devices. You’ll oversee quality plans, design input validation, and risk management to verify that design requirements are met in development, transfer, and post-market performance. You analyze product quality and efficiency of realization processes, initiating CAPA when needed. This position offers a chance to contribute to regulatory compliance and continuous improvement in a global medical device setting. Compensation / Benefits * Develop and oversee quality plans covering the full product lifecycle * Provide independent oversight of design input, V&V, transfer, and field performance * Validate key design inputs (usability, reliability, performance, safety, security, etc.) * Oversee execution of Quality Plan and Risk Management activities throughout the lifecycle * Conduct independent technical assessments of product quality and post-market quality analysis * Perform post-market data analysis to inform design and realization processes * Initiate field actions/CAPA when required Tasks * 5+ years in FDA-regulated medical devices with focus on Design Assurance/Control * Strong knowledge of ISO 13485 / 9001 / FDA / Canada regulatory requirements * Experience in Risk Management (ISO 14971), FMEA/DFMEA, DV/DA, root cause analysis, defect management * Experience with design quality tools for defect tracking, design traceability, and design for reliability * Experience using PMS data analytics to drive continuous improvement * Bachelor’s Degree in Quality, Engineering or similar * Ability to travel up to 10% * US work authorization Key requirements * PTO * 401k with company match * HSA with company contribution * stock purchase plan * education reimbursement * total rewards benefits program

5+ post-market data analysis to inform design and realization processes * Initiate field actions/CAPA when required Tasks * 5+ years in FDA-regulated medical devices with focus on Design Assurance/Control * Strong knowledge of ISO 13485 / 9001 / FDA / Canada regulatory requirements * Experience in Risk Management (ISO 14971), FMEA/DFMEA, DV/DA, root cause analysis, defect management * Experience with design quality tools for defect tracking, design traceability, and design for reliability * Experience using PMS data analytics to drive continuous improvement * Bachelor’s Degree in Quality, Engineering or similar * Ability to travel up to 10% * US work authorization Key requirements * PTO * 401k with company match * HSA with company contribution * stock purchase plan * education reimbursement * total rewards benefits program