Design Quality Engineer I
MedTechPharmaRegulatory AffairsQuality Assuranceheoremacroinform
Job description
We anticipate the application window for this opening will close on - 18 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Our Medtronic Surgical team is working to bring the benefits of minimally invasive surgery (MIS) to more people and places through a portfolio of robotic and digital solutions. Together, we are working to broaden options and expand access globally for hospitals, surgeons, and patients. As a Design Quality Engineer I, you will play a critical role supporting the design quality, risk management, and U.S. launch of innovative surgical robotics systems, capital equipment, and instrumentation, including the Hugo™ platform. This design-focused quality role works at the intersection of R&D, manufacturing, supplier quality, and regulatory, supporting medical device designs from early development through manufacturing transfer and post-launch support. You will translate design and risk requirements into effective manufacturing controls, ensuring quality is built into the product from the outset, with a specific focus on hardware systems, electrical safety, and capital equipment performance in the field , while operating with a high degree of autonomy and cross-functional influence. Key Responsibilities Lead and support design quality and risk management activities , including DFMEA development and cross‑functional risk reviews Own and maintain elements of the Product Risk Management File throughout the product lifecycle Partner with R&D to embed quality and risk controls into system, hardware, and design requirements Translate design and CTQ requirements into robust manufacturing controls and inspection strategies, including hardware performance and safety requirements Collaborate with manufacturing teams to support design transfer, production readiness, and issue resolution Support supplier qualification and supplier quality activities, including design‑related inputs Support design quality activities for capital equipment and electromechanical systems , including hardware integration and system-level considerations Contribute to electrical safety and compliance activities (e.g., IEC 60601) , including risk identification and test strategy alignment Partner with cross-functional teams to ensure serviceability, reliability, and field maintenance considerations are incorporated into product design Perform quality testing, statistical analysis, and root-cause investigations to address nonconformances and CAPAs Participate in design reviews, change management, and technical decision-making Support complaint investigations, post-market activities, and U.S. launch hyper-care efforts Required Qualifications Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or a related hardware-focused technical discipline Preferred Qualifications Experience working with capital equipment or complex electromechanical medical devices Familiarity with IEC 60601 or other electrical safety standards Experience with hardware systems, PCBAs, or electromechanical components 1-3 years of experience in Electrical Engineering, Quality Engineering, Design Quality, Manufacturing Quality, or related roles Background in a regulated industry (medical devices strongly preferred; robotics, capital equipment, or aerospace highly relevant) Hands-on experience with design risk management, including DFMEA Experience working cross-functionally with manufacturing teams and suppliers Experience supporting U.S. product launches, post-market surveillance, complaints, and/or CAPAs Familiarity with statistical analysis tools (e.g., Minitab, JMP) Prior exposure to manufacturing or operations environments Exposure to serviceability, field support, or equipment maintenance considerations in product design Ability to work independently, manage priorities, and influence without direct authority Strong written and verbal communication skills For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do
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