Sr. Design Quality Engineer

As a Sr. Design Quality Engineer at Medtronic's CST ETCareers, you will be a pivotal force in ensuring the quality and regulatory compliance of software design and development for medical devices, stand-alone software, non-products, and firmware components. You'll facilitate the robust application of design controls throughout product development and released product management, contributing to Medtronic's commitment to life-changing healthcare technology.

A Day in the Life

You will drive design quality and regulatory compliance by:

• Reviewing new and modified product design documentation for critical quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Mentoring junior quality engineers, providing essential guidance and support in quality engineering practices.
• Ensuring that product development projects and changes to existing products comply with IEC 62304, FDA Quality System Regulations, EU MDR, and internal standards.
• Participating on cross-functional teams to develop comprehensive product risk management files (e.g., risk management plans, risk assessments, DFMEA, and risk management reports).
• Partnering with Software Engineering to assess risk, develop software design plans and documentation, ensure code and integration reviews, and demonstrate software capability and maturity.
• Assisting in the creation of verification and validation plans, protocols, and reports, overseeing testing and analysis for standards and product requirements compliance.
• Possessing hands-on experience in software anomaly evaluation and disposition, complaint investigation, and NC/CAPA.
• Ensuring successful transfer of new products to production facilities by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools.
• Reviewing Design History Files and Technical Files for conformance to applicable requirements.
• Participating in audits when appropriate.
• Demonstrating mastery of software development and testing methodologies.
• Independently developing test strategies for new, pre-concept features in development.
• Ensuring applicability to SOUP / OTS validations in the product development lifecycle.
• Participating on the Change Control Board (CCB) to decide upon Change Request (CR) implementation.
• Assessing the compliance of the software development methodology to the approved process.
• Participating in and providing input to training on department procedures and policies.
• Possessing hands-on experience on Software Risk Management and Design Controls.
• Facilitating hazard analysis and SFMEA sessions and preparing the risk management file.
• Acting as the subject matter expert on risk management for one or more products/platforms.
• Applying quality system regulations, applicable standards, and guidance to multiple projects.
• Developing templates and training based on quality system regulations, applicable standards, and guidance.
• Independently reviewing all SW deliverables to ensure compliance with the development process and standards.
• Delivering presentations to the QA organization on project status and issues, and providing training to departments outside of QA.
• Providing Quality support to facilitate the resolution of product complaints and/or safety issues.
• Providing support to the Regulatory Department in writing technical submissions.

Required Knowledge and Experience

• B.E. or B.Tech degree.
• Minimum 6-8 years of quality engineering experience or equivalent, and overall 8-12 years of experience.
• Familiarity with ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EU MDR, and product-specific industry standards.
• Strong in software design and development, software verification and validation activities.
• Previous experience working in a cross-functional team environment.
• Familiarity with statistical software tools (Minitab, Stat Graphics).
• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
• Good verbal and written communication skills, including protocol/report development and technical presentations.
• Computer literate and experienced with PCs, networks, applications, and the software development life cycle.
• Knowledge in cybersecurity.
• Travel may be required.

Nice to Haves

• ASQ CQE, CQA, CSQE, and/or CRE certification.
• ISO 13485 Internal Auditor / Lead Auditor Certification.
• Lean Six Sigma Green Belt or Black Belt.
• Experience with Comparative Statistical techniques, sampling plans, GRR, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.
• Familiarity with DMAIC or DMADV (DFSS) methodologies.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package. We are committed to our employees, recognizing their contributions and providing a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity.