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Design Quality Engineer II - Hardware (Surgical Robotics)
Women Veterans Interactive
- North Haven, New York, United States
- North Haven, New York, United States
Über
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.
This design-focused quality role works at the intersection of R&D, manufacturing, supplier quality, and regulatory activities, supporting medical device designs from early development through manufacturing transfer and post-launch support.
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 components
2–5 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
Physical Job Requirements:
The above statements describe the general nature and level of work being performed for this position. The physical demands described within the Responsibilities section 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.
U.S. Work Authorization & Sponsorship:
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.
Benefits & Compensation:
Competitive salary range: $79,200.00 - $118,800.00 (US excluding Puerto Rico). Eligible for Medtronic Incentive Plan (MIP). Comprehensive benefits including health, dental, vision, HSA, FSA, life insurance, long‑term disability, dependent daycare, tuition assistance, 401(k) with match, paid time off, holidays, employee stock purchase plan, and additional compensation plans.
Equal Employment Opportunity (EEO):
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status or any other characteristic protected by federal, state or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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Sprachkenntnisse
- English
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