Principal Quality Engineer

Employment Type

: Full-Time

Industry

: Engineering



Job Description:

• 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).

• Ensure that project teams comply with all applicable regulations, standards, best practices, and Medtronic procedures.

• 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.

• Participate in technical reviews (software, electrical, mechanical), formal design reviews, Change Control Board (CCB) reviews, and Post Market Vigilance trend reviews.

• Apply and improve advanced technical principles, theories, and concepts in the monitoring and coordination of various design, development, testing, and quality activities.

• Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.

• Utilize expert knowledge of embedded systems, mechanical, electrical, software design principles, development lifecycles, and design controls.

• Provide guidance and direction regarding sample size selection commensurate with risk, and statistical analysis.

• 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.

• 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).

• 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).

• Experience in risk evaluation techniques, e.g. HHE/HHA, PHA, SFMEA, DFMEA, PFMEA & FTA.

• Provide quality support to facilitate the rapid resolution of product complaints and/or safety issues.

• Experience in supporting CAPA projects and activities.

• Experience in OEM supplier quality management.

• Experience in manufacturing quality support.

• Review DHF and Technical Files for conformance to applicable requirements.

• Assist with internal, external, and supplier audits.

• Provide training to project teams on procedures, verification, validation, statistical methods and design controls.

• Oversee testing and analysis for standards and product requirements compliance.

• Provide regulatory support in for recalls, corrections and removals decisions and writing technical submissions.

Must Have Requirements:

• Bachelor’s degree in Engineering or Science field with minimum 12+ years of work experience (or master’s degree with minimum 8+ years of work experience) in hardware, software and/or quality assurance.

• At least 7+ year experience in the medical device industry, preferably as a design quality engineer (DQE).

• 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.

• Excellent troubleshooting and investigation skills including root cause failure analysis, test protocol/report development and technical documentation.

• Excellent verbal and written communication skills, including technical presentations.

Nice to Have Preferred Qualifications:

• Comparative statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.

• DFSS, DMAIC or DMADV, DOE, SPC and capability analysis.

• ASQ CQE, CQA, CSQE and/or CRE certification.

• Familiar with statistical software tools (Minitab, Stat Graphics, Statistica)

• Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS.

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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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