Senior Design Quality Engineer

Summary : We are looking a Senior Design Quality Engineer to support quality assurance activities for electromechanical medical devices and combination products, including infusion systems and drug-device delivery platforms. This role works closely with R&D, Manufacturing, and Regulatory teams to ensure products are developed and manufactured in compliance with medical device quality and regulatory requirements.This is a hands-on quality engineering role focused on design controls, verification & validation, risk management, and product lifecycle quality support.Roles & Responsibilities:Support quality activities across the product lifecycle for electromechanical and combination medical devices.Apply Design Controls (21 CFR 820.30 / ISO 13485) during product development.Review and approve design inputs/outputs, test protocols, and validation reports.Support design verification and validation testing for mechanical, electrical, and software-controlled systems.Participate in risk management activities (FMEA, hazard analysis, risk reviews).Ensure traceability from user needs requirements verification validation.Support change control and engineering change assessments.Investigate quality issues and support root cause analysis and CAPA.Review DHF/DMR documentation for completeness and compliance.Partner with engineering and manufacturing teams to ensure quality is built into product design.Support supplier quality activities for critical components.Contribute to regulatory submission documentation as needed.Education & Experience :Bachelor's and Master's degree in Mechanical, Electrical, Biomedical, or related Engineering field.8+ years Quality Engineering or Quality Assurance experience in medical devices.Hands-on experience with electromechanical medical devices.Strong working knowledge of:Design Controls.Risk Management (ISO 14971).ISO 13485 / FDA 21 CFR 820.Experience supporting verification & validation testing.Experience with DHF documentation and change control.Experience performing investigations and CAPA.Ability to work cross-functionally with engineering teams.Preferred:Experience with infusion pumps or drug delivery systems.Combination product experience.Knowledge of IEC 60601, IEC 62304, or IEC 62366.Experience supporting 510(k) or other regulatory submissions.ASQ CQE / CQA certification.Experience with eQMS systems.