Sr Reliability Engineer

Medtronic plc; United States; On-site; USD 107,000 - 161,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with match

Tuition assistance

Employee Stock Purchase Plan

Job summary

Medtronic is seeking a Senior Supplier / Manufacturing Quality Engineer for NPD. You will influence design for manufacturability, qualify manufacturing processes, and manage supplier performance to ensure continuous supply and successful design transfer. Travel to suppliers in the US and internationally is required.

The role requires a strong background in manufacturing processes, process development, controls, validation, and supplier management within a regulated medical device environment.

Qualifications

• Bachelor’s degree in engineering and 4+ years relevant experience.
• Knowledge of plastics, metals, electronics and/or product level assembly manufacturing processes.
• Extensive understanding of GD&T, FMEA and regulatory requirements.
• Strong analytical and problem-solving skills with ability to perform root-cause analysis and collaborate cross-functionally.

Responsibilities

• Supplier selection and qualification ensuring quality parts, materials, and services.
• Monitor parts from acquisition through manufacturing cycle, identify and resolve supplier issues.
• Manage PPAP processes including process validation and technical writing.
• Oversee supplier change requests, audits, and supplier performance reviews.
• Support design transfer to translate design specs into production specs.

Skills

Manufacturing processes

GD&T

FMEA

Regulatory knowledge

Root cause analysis

Leadership

Communication

Education

Bachelor’s degree in engineering or related field

Tools

SAP

Trackwise

Windchill

Agile

Job description

We anticipate the application window for this opening will close on - 27 Nov 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.

Job Title

Senior Supplier / Manufacturing Quality Engineer -- NPD

Location

Company: Medtronic

Job Description

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

Qualifications

Minimum Requirements:

• 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.

Benefits & Compensation

• Salary ranges for U.S (excl. PR) locations (USD):$107,200.00 - $160,800.00
• 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.
• 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.

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.

Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

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, click here: http://www.uscis.gov/e-verify/employees.

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.

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.

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