Design Quality Engineer II - Hardware; Surgical Robotics
Job in
North Haven, New Haven County, Connecticut, 06473, USA
Listed on 2026-06-27
Listing for:
Medtronic
Full Time
position Listed on 2026-06-27
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Electronics Engineer, Manufacturing Engineer
Job Description & How to Apply Below
We anticipate the application window for this opening will close on - 26 Jun 2026
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*
* At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
This position is onsite 4 days per week in North Haven, Connecticut.
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 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
** Required Qualifications*
* + 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…
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