> Markdown version of [/jobs/ext/1060748-design-quality-engineer-ii-hardware-surgical](https://www.wearedevelopers.com/jobs/ext/1060748-design-quality-engineer-ii-hardware-surgical). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Design Quality Engineer II - Hardware (Surgical... - **Company:** Medtronic Inc. - **Location:** North Haven, CT, United States - **Experience:** Starter - **Salary:** $79,200.0 - $118,800.0 - **Contract:** Temporary contract - **Skills:** Adobe InDesign, Failure Mode Effects Analysis, Hardware Design, Minitab, Strategies of Testing, JMP (Statistical Software) - **Published:** June 19, 2026 - **Apply:** https://www.juju.com/job/00000000g9ne3y ## About the Role + Bachelor's degree in Electrical Engineering, Biomedical Engineering, or a related hardware-focused technical discipline, plus:2+ years of related work experience OR a Master's degree with 0-2 years of related work experience 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 components2-5 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. ## Description As a **Design Quality Engineer II** , 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 ## Related Videos - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Quantum Computing - The tiny and the big challenges](https://www.wearedevelopers.com/videos/934-quantum-computing-the-tiny-and-the-big-challenges) - [The future of automotive mobility: Upcoming E/E architectures, V2X and its challenges](https://www.wearedevelopers.com/videos/374-the-future-of-automotive-mobility-upcoming-e-e-architectures-v2x-and-its-challenges) - [Breaking the Hardware Mindset: Overcoming Barriers to System-Level Innovation](https://www.wearedevelopers.com/videos/1635-breaking-the-hardware-mindset-overcoming-barriers-to-system-level-innovation) - [From Bedside Beeps to Interoperable Bytes – Getting your medical devices ready to talk the IEEE 11073 language](https://www.wearedevelopers.com/videos/771-from-bedside-beeps-to-interoperable-bytes-getting-your-medical-devices-ready-to-talk-the-ieee-11073-language) - [Building the Nervous System of AI - Michael Kagan (NVIDIA)](https://www.wearedevelopers.com/videos/2133-building-the-nervous-system-of-ai-michael-kagan-nvidia) ## Related Articles - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [What Jobs Can You Get with a Software Engineering Degree?](https://www.wearedevelopers.com/magazine/398-what-jobs-can-you-get-with-a-software-engineering-degree) - [Where to Find Entry-Level Software Engineering Jobs](https://www.wearedevelopers.com/magazine/397-where-to-find-entry-level-software-engineering-jobs) - [Is Software Engineering Hard?](https://www.wearedevelopers.com/magazine/448-is-software-engineering-hard) - [Top Characteristics of a Software Engineer](https://www.wearedevelopers.com/magazine/166-top-characteristics-of-a-software-engineer) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering)