Senior Design Quality Engineer
Job Summary
As a Senior Design Quality Engineer at Medtronic, you will ensure the highest quality of our medical devices across their entire lifecycle, with a focus on end-to-end product development encompassing software, mechanical, and embedded systems. You will play a pivotal role in applying design controls, conducting rigorous risk management, and ensuring compliance with global regulatory standards, contributing directly to Medtronic's mission of healthcare innovation.
A Day in the Life
You will be instrumental in upholding Medtronic's commitment to quality by:
- Reviewing New Product Introduction (NPI) and Released Product Management documentation for quality characteristics like manufacturability, serviceability, testability, reliability, and product requirements.
- Ensuring compliance of product development projects and changes to existing products with ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, FDA Quality System Regulations, EU MDR, and in-house standards.
- Participating on cross-functional teams to develop comprehensive product risk management files (e.g., risk management plans, assessments, hazard analyses, DFMEA, SFMEA, UFMEA).
- Reviewing and participating in Cybersecurity assessments.
- Partnering with Software, Mechanical, and Embedded engineering teams to assess risk, develop design plans and documentation, ensure proper reviews, and demonstrate product 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 (Non-Conformance/Corrective and Preventive Action).
- 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.
- Demonstrating strength in software design and development, and software verification and validation activities.
- Reviewing mechanical drawings, PCB layouts, mechanical/system testing, and firmware testing, as well as human factors/usability assessment, radio frequency testing, sterilization testing, biocompatibility testing, shelf-life testing, labeling, and packaging.
- Reviewing end-to-end product development deliverables (software, mechanical, firmware).
- 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.
- Ensuring applicability to SOUP / OTS validations in product development.
- Participating on the Change Control Board (CCB) to decide upon Change Request (CR) implementation.
- Participating in and providing input to training on department procedures and policies.
- Possessing hands-on experience in Risk Management and Design Controls.
- 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 product deliverables for compliance with development processes and standards.
- Delivering presentations to the QA organization on project status and issues, and providing training to departments outside of QA.
- Demonstrating ability to effectively play multiple roles on a cross-functional team (contributor, subject matter expert, leader, facilitator).
- 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 8-13 years of experience.
- Good verbal and written communication skills, including protocol/report development and technical presentations.
- Familiarity with statistical software tools (Minitab, Stat Graphics).
- Previous experience working in a cross-functional team environment.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package. We are committed to our employees, recognizing their contributions and providing resources to support you at every career and life stage.
About Medtronic
Medtronic leads global healthcare technology, boldly attacking 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 95,000+ passionate people. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people, leveraging talent, diverse perspectives, and courage to engineer the extraordinary.
