At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

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.

• Ensures internal quality processes procedures and systems are compliant to all governing standards.

• Collaborates with engineering and manufacturing functions to ensure quality standards are met.

• 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.

• Works with the customer and local Design teams to ensure appropriate Design Outputs have been provided to the manufacturing team that enable high product quality via Process and Test Method Validations.

• Supports manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development IQ Process Development (characterization) OQPQ and Test Method Development and Validation.

• Uses knowledge of statistics on acceptance criteria DOE and comparison testing to support manufacturing engineers in the development of compliant test plans and reports.

• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

• Supports risk assessment processes for manufacturing and development including process FMEA ensuring risk assessments are thorough and documentation meets all governing requirements.

• Develops and supports solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards issue reporting and other performance measures.

• Supports CAPA investigations improvements and effectiveness verification testing.

• Lead and/or support investigations of non-conforming product materials or processes through the coordination of cross functional teams while simultaneously performing the role of Quality Engineer. Responsible for documentation of the non-conformances identification of population containment of population and communication of non-conformance to applicable parties.

• Supports and drives proper change control procedures and collaborates with change owners on their implementation strategies and change documentation.

• Facilitates group meetings and project leadership that drives comprehensive technical solutions in your quality domain.

• Communicates clearly regarding technical issues and solutions

• 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.

Required Knowledge and Experience: Requires a Baccalaureate degreein Engineering Science or technical field and minimum of 4 years of relevant experience in Engineering and/or Quality OR Masters degree in Engineering Science or technical field with a minimum of 2 years relevant experience OR PhD in Engineering Science or technical field with 0 years relevant experience.

Nice to Have:

• Experience with electronics manufacturing including wafer fabs and microelectronics assembly (SMT and/or chip and wire).

• Strong background in Equipment Development IQ Process Characterization OQPQ and Test Method Development and Validation.

• Six Sigma or Lean Sigma belt certification

• DRM or DFSS certification

• Experience with internal and external audits including FDA MDSAP and/or TUV.

• 4 years of engineering experience in a medical device manufacturing environment

• 4 years of Process Quality or Process Engineering experience.

• Strong understanding of medical device manufacturing processes and products

• Experience with general quality principles procedures and methodologies

• Strong understanding of regulatory requirements (i.e.: ISO FDA-GMP etc.)

• Strong statistical analysis techniques & DOE design and execution

• Strong overall communication both in technical writing and presentation skills as well as experience with presentation tools and applications

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.

U.S. Work Authorization & Sponsorship

At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful 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 lifewhere your unique background and perspective are valued.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A 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.

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

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 95000 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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.