New Product Development Senior Supplier Quality Engineer

RiseMe; North Haven (CT); On-site; USD 110,000 - 140,000; Full time

Job summary

Medtronic is seeking a Senior Quality Engineer to join the Surgical Operating Unit, focusing on manufacturability, supplier collaboration, and robust process development. You will drive quality improvements through CAPA, PPAP, and validation activities, ensuring design transfer and regulatory compliance across production.

The role demands extensive technical knowledge of GD&T, FMEA, and ISO/FDA standards, with strong leadership and cross-functional influence in a fast-paced environment.

Qualifications

• Education: Degree in engineering or related technical field with 4+ years experience; or advanced degree with 2+ years.
• Extensive understanding of manufacturing processes, GD&T, FMEA, and DFX principles.
• Regulatory knowledge in regulated environments (FDA/ISO).
• Strong analytical, root-cause and cross-functional collaboration skills.
• Excellent written and verbal communication and leadership in projects.

Responsibilities

• Select and qualify suppliers ensuring quality parts and services.
• Monitor parts through manufacturing cycle and resolve supplier issues.
• Manage NCMRs and supplier change requests with reporting.
• Qualify materials via PPAP and perform process validation.
• Drive supplier performance improvements and CAPA management.
• Oversee IQ/OQ/PQ validation and Master Validation Planning.
• Collaborate to capture process controls in design and DFM/DFMEA.

Skills

Leadership

Communication

Problem solving

Regulatory knowledge

Education

Bachelor's degree in engineering

Advanced degree in a related field

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.

A Day in the Life

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 teamplayer 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.

• The job requires occasional travel to visit suppliers within the United States and internationally.

Qualifications:

MinimumRequirements:

• 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:

• Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.

• Regulatory Knowledge: In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.

• Technical Skills: Proficient in quality management systems, risk management, regulatory compliance, and statistics. Lead auditor experience.

• Other: 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.

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.

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.

TECHNICAL SPECIALIST CAREER STREAM:

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation – while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor.
Works independently under limited supervision to determine and develop approach to solutions.
Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area.
Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
Makes improvements of processes, systems or products to enhance performance of the job area.
Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors.
Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision‑making.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.
May manage projects, requiring delegation of work and review of others' work product.

Required Knowledge and Experience: Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.

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.