â€¢ Collaborate, review, and approve all project plans, requirements, specifications, test protocols, test results, traceability, and risk management file elements and maintain a robust Design History File (DHF).
â€¢ Ensure that project teams comply with all applicable regulations, standards, best practices, and Medtronic procedures.
â€¢ Participate on cross-functional teams to review and prioritize marketing requirements and to develop concise, unambiguous, non-conflicting and feasible product requirements that support market needs.
â€¢ Participate in technical reviews (software, electrical, mechanical), formal design reviews, Change Control Board (CCB) reviews, and Post Market Vigilance trend reviews.
â€¢ Apply and improve advanced technical principles, theories, and concepts in the monitoring and coordination of various design, development, testing, and quality activities.
â€¢ Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
â€¢ Utilize expert knowledge of embedded systems, mechanical, electrical, software design principles, development lifecycles, and design controls.
â€¢ Provide guidance and direction regarding sample size selection commensurate with risk, and statistical analysis.
â€¢ EE/ME Design & Development: Design Margin, Component Derating, Creep & Clearance, In Circuit Test, IPC, Stack Up and Tolerance Analysis, Key Inspections Analysis Material Analysis, Design of Experiment & Reliability Analysis.
â€¢ Generate documentation at the project level, including software, hardware, and system risk assessments, Essential Requirements compliance matrices (ERM), and General Safety and Performance Requirements (SPRs).
â€¢ Lead cross-functional teams to create and maintain the risk management file (develop risk management plan, perform product risk assessment, facilitate failure mode effects analysis, and generate risk management report).
â€¢ Experience in risk evaluation techniques, e.g. HHE/HHA, PHA, SFMEA, DFMEA, PFMEA & FTA.
â€¢ Provide quality support to facilitate the rapid resolution of product complaints and/or safety issues.
â€¢ Experience in supporting CAPA projects and activities.
â€¢ Experience in OEM supplier quality management.
â€¢ Experience in manufacturing quality support.
â€¢ Review DHF and Technical Files for conformance to applicable requirements.
â€¢ Assist with internal, external, and supplier audits.
â€¢ Provide training to project teams on procedures, verification, validation, statistical methods and design controls.
â€¢ Oversee testing and analysis for standards and product requirements compliance.
â€¢ Provide regulatory support in for recalls, corrections and removals decisions and writing technical submissions.
Must Have Requirements:
â€¢ Bachelorâ€™s degree in Engineering or Science field with minimum 12+ years of work experience (or masterâ€™s degree with minimum 8+ years of work experience) in hardware, software and/or quality assurance.
â€¢ At least 7+ year experience in the medical device industry, preferably as a design quality engineer (DQE).
â€¢ Strong familiarity with ISO 13485, 21 CFR 820, 21 CFR 806, ISO 14971, IEC 62304, IEC 61000, EU MDD/MDR, EN ISO 60601-1, EN ISO 60601-1-8, and EN ISO 80601-2-12.
â€¢ Excellent troubleshooting and investigation skills including root cause failure analysis, test protocol/report development and technical documentation.
â€¢ Excellent verbal and written communication skills, including technical presentations.
Nice to Have Preferred Qualifications:
â€¢ Comparative statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.
â€¢ DFSS, DMAIC or DMADV, DOE, SPC and capability analysis.
â€¢ ASQ CQE, CQA, CSQE and/or CRE certification.
â€¢ Familiar with statistical software tools (Minitab, Stat Graphics, Statistica)
â€¢ Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS.
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