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 LifeA career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.
The Quality Engineer II - New Product Introduction (NPI) is responsible for ensuring product and process quality throughout development, validation, process transfer, and production readiness for machining and selected secondary operations such as anodizing and final pack. This role provides quality oversight to cross-functional teams to ensure manufacturing processes, equipment, components, and documentation meet design intent, regulatory requirements, and Medtronic Quality Management System expectations.
Key responsibilities include leading and supporting risk-based validation activities (IQ/OQ/PQ), confirming process and equipment readiness for production release, and ensuring effective component qualification, change control, and lifecycle support. The role is expected to drive compliance with GMP, FDA, and ISO requirements through disciplined documentation, traceability, investigation support, and audit readiness. This position also strengthens product and process robustness by analyzing data, identifying quality risks, supporting nonconformance and CAPA activities, and partnering closely with Manufacturing, Engineering, Supply Chain, and Quality functions to enable successful product launch and sustained operational performance.
Responsibilities may include the following and other duties may be assigned.
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
- Provides quality engineering support for new product introduction activities, including process development, validation, qualification, and production readiness.
- Partners with Manufacturing, Process Development, and Engineering teams to establish and maintain effective quality controls for machining and secondary manufacturing processes.
- Develops and implements methods for inspection, testing, validation, and process evaluation to ensure equipment and products consistently meet defined requirements.
- Uses statistical analysis and quality engineering tools to assess process capability, support component and process qualification, and investigate products or materials that do not meet specifications.
- Ensures investigations, corrective actions, validations, and supporting documentation are compliant, technically sound, and inspection-ready.
- May lead or support activities related to process quality, incoming materials, product evaluation, validation, change management, and continuous improvement as part of product lifecycle support.
Required Knowledge and Experience: Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.Engineering degree requiredMust Have:- Strong knowledge of Process Validation (IQ/OQ/PQ) and risk-based validation approaches
- Experience with Machine Complete / equipment qualification and production readiness
- Proficiency in risk management tools (FMEA, hazard analysis, risk assessments)
- Knowledge of statistical methods (SPC, capability analysis, DOE preferred)
- Root cause investigation tools (5 Why, Fishbone, DMAIC)
Nice to Have- Bachelor's degree required in Engineering, preferably Mechanical, Industrial, Chemical.
- Minimum of 3 years of relevant engineering or quality experience required, or a Master's Degree in Engineering with at least one co-op or internship experience, preferably within the medical device or other regulated manufacturing industry.
- Demonstrated technical writing capability for protocols, reports, investigations, and quality documentation.
- Working knowledge of Quality Management Systems, including document control, nonconformance management, CAPA, change control, and risk management.
- Familiarity with regulated manufacturing requirements and standards such as FDA Quality System Regulation, ISO 13485, and GMP expectations.
- Knowledge of equipment, process, and product validation concepts, including IQ, OQ, PQ, and risk-based validation approaches.
- Experience using data analysis and statistical methods such as SPC, capability analysis, or DOE to support investigations and continuous improvement.
- Lean Six Sigma Green Belt certification or training preferred.
- Hands-on experience with statistical software such as Minitab or equivalent tools for trending, capability studies, and root cause analysis.
- Experience with automation, data extraction, or basic programming tools such as VBA, Python, or similar platforms to support reporting and process analysis.
- Experience applying root cause analysis and risk assessment tools such as 5 Whys, Fishbone, or FMEA in manufacturing or quality environments.
- Working knowledge of manufacturing systems or MES tools to support process controls, data integrity, and investigation activities.
- Strong critical thinking, problem-solving, communication, and cross-functional collaboration skills in a fast-paced manufacturing environment.
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 RequirementsThe 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.
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.
Join us in our mission to alleviate pain, restore health, and extend life-where your unique background and perspective are valued.
Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
Medtronic benefits and compensation plans
About MedtronicWe 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.
Learn more about our business, mission, and our commitment to diversity here
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.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find
here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
