New Product Development Senior Supplier Quality Engineer

COV Covidien LP; North Haven (CT); On-site; USD 98,000 - 148,000; Full time

Job summary

Medtronic seeks a Senior Quality Engineer in the Surgical Operating Unit to influence design for manufacturability, oversee supplier processes, and ensure robust manufacturing. You will manage supplier qualification, PPAP, and process validation while supporting medical device development and design controls in a regulated environment.

The role requires strong analytical skills, cross-functional collaboration, and leadership to drive quality improvements, supplier CAPA, and successful design

Qualifications

• Bachelor's degree in engineering or related technical field and 4+ years of relevant experience, or advanced degree with 2+ years.
• Extensive understanding of manufacturing processes for plastics, metals, electronics and/or product assembly.
• Strong knowledge of GD&T, FMEA and DFX principles within a regulated environment.
• Experience with supplier management, PPAP, process validation and regulatory compliance.
• Proven analytical, problem-solving and cross-functional collaboration skills.
• Leadership and project management capabilities with multi-project exposure.

Responsibilities

• Select and qualify suppliers to ensure quality parts, materials and services.
• Monitor parts through manufacturing, identify and resolve supplier-related issues.
• Evaluate supplier capabilities to meet product, process, quality and business needs.
• Manage NCMRs and supplier change requests with proper reporting.
• Maintain Approved Supplier List through audits and agreements.
• Qualify materials via PPAP including process validation and technical writing.
• Drive supplier performance improvements and reduce escapes through CAPA and reviews.
• Oversee IQ/OQ/PQ validation and Master Validation Planning in NPD.
• Perform statistical analysis of manufacturing process performance.
• Collaborate to capture process controls in design and manufacturability discussions.

Skills

GD&T

FMEA

DFX

Supplier management

Process validation

Statistics

Project management

Design for Manufacturability and ASB

Education

Bachelor's degree in engineering

Advanced degree

Tools

SAP

Trackwise

Windchill

Agile

Job description

We anticipate the application window for this opening will close on - 23 Oct 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.

Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Senior Quality Engineer to join our innovative team. This role will be in the Surgical Operating Unit within the new product development quality team to influence design based on manufacturability, inspection and assembly, interact with suppliers (internal and external) to develop robust processes to manufacture the parts and assemblies, qualify the manufacturing processes established to produce sustainable supply and maintain supply and manufacturing continuity until product transfer. The ideal candidate will bring a strong background in manufacturing processes, manufacturing process development, process controls, process validation and supplier management. The role also supports medical device product development, and a solid understanding of design controls and regulatory compliance requirements is preferred. This position requires a strong team player who is a self-starter, inquisitive, and a fast learner. This role will be pivotal in ensuring the development of medical devices that drive successful design transfer.

Key Responsibilities

• Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services.
• Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems.
• Evaluate supplier technical and manufacturing capabilities to meet product, process, quality, and business requirements as an input to supplier selection.
• Manage Non-Conformance Material Reports (NCMRs) for material, components and production related issues, ensuring trends are identified, analyzed, and addressed across incoming, production, and sterilization areas.
• Manage suppliers' change requests, including communication, project management, and regular reporting.
• Manage the Approved Supplier List, from supplier evaluation, supplier agreement, supplier audits to supplier acceptance.
• Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management.
• Drive supplier performance improvement and reduce escapes to manufacturing through effective issue escalation, Supplier CAPA management, and Quality Performance Reviews.
• Oversee Process validation (IQ/OQ/PQ) and Master Validation Planning in new product development.
• Perform Statistical analysis of manufacturing process performance outputs.
• Oversee Process Failure Mode and Effect Analysis (internally and externally).
• Collaborate cross functionally to ensure process limitations are captured within the design control, including Design Failure Mode and Effects Analysis and Design for Manufacturability and Assembly activities.
• Collaborate cross functionally to ensure essential components, product features and respective process controls are identified.
• Ensure Design Transfer effectively translates design specifications into production specifications.
• Use project management skills to ensure that supplier processes are developing at the appropriate cadence to support engineering builds and Design Verification and Validation.

Qualifications

• Education: Minimum bachelor’s degree in engineering, or a related technical field AND minimum 4 years of relevant experience. OR advanced degree with a minimum of 2 years relevant experience.
• Technical Knowledge: Extensive understanding of manufacturing processes for plastics, metals, electronics and/or product level assembly. Extensive understanding of GD&T, FMEA, DFX principles.
• Regulatory Knowledge: Extensive experience in a regulated environment.
• Problem-Solving: Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.
• Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.
• Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously.

Preferred Qualifications

• Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.
• In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.
• Proficient in quality management systems, risk management, regulatory compliance, and statistics.
• Lead auditor experience.
• Basic knowledge of human anatomy/physiology and surgical procedures.
• Tools: SAP, Trackwise, Windchill, Agile.

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.

About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies, and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

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 Day in the Life 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.

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. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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.

Benefits & Compensation

Salary ranges for U.S (excl. PR) locations (USD):$98,400.00 - $147,600.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:

• Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
• Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

We lead global healthcare technology and boldly attack 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. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life‑changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight‑driven care. Fresh viewpoints. Cutting‑edge AI, data, and automation. You’re shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [e-mail]. To request removal of your personal information from our systems please email [e-mail].