Senior Design Quality Engineer

Sr. Design Quality Engineer

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life Of:

• Critically review new and modified product designs to determine their impact to existing or new product requirements and their effect on, patient safety, standards compliance, and reliability.
• Ensure that design changes to existing products are conducted in compliance with Medtronic's QMS, ISO13485, EU-MDR and the FDA Quality System Regulations.
• Lead cross-functional teams to develop product risk management files (risk management plan, risk assessments, dFMEA, and risk management report).
• Assist in the creation of verification and validation test plans, protocols and reports. Review testing and analysis for standards and product requirements compliance.

Key Skills & Experience

• 4+ years of Quality experience with a Bachelors Degree
• 2+ years of Quality experience with a Masters Degree
• Experience in the Medical Device Industry or a similar role.
• Good verbal and written communication skills through English, including protocol / report development and review.
• Experience in ISO 13485
• Experience in Risk Management ISO 14971
• Working knowledge of IEC standards.
• Familiar with IEC 60601 and product specific industry standards.
• Experience of EU-MDR regulations.
• Experience of verification/validation test plan development.
• Experience with CAPA and root cause failure analysis.

Nice to Have

• Previous experience in Electronic, PCB design, Hardware.
• Working knowledge of Electronic Schematics, circuit simulation and analysis, PCB Assembly Drawings.
• Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.
• Familiar with statistical software tools (Minitab, Stat Graphics, Statistical),
• Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS.
• Familiar with DMAIC or DMADV(DFSS) methodologies.
• DFSS / Lean Green Belt or Black Belt.

Medtronic offer a competitive salary and flexible Benefits Package