Senior Reliability Engineer - NMPH - Fridley, MN (Onsite)

We anticipate the application window for this opening will close on - 28 Feb 2025

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 LifeIn this exciting role as a Senior Reliability Engineer you will have responsibility for many aspects of product quality and reliability for products that are released as part of Medtronic Neuromodulation organization. In this role, you will investigate issues and analyze the risks for products in the field. This includes trends in complaint data, labeling, software, and hardware related issues. You will also provide risk and reliability engineering support for released product design and process changes. The Senior Reliability Engineer ensures that all analysis meets acceptable reliability standards, and that documentation is compliant with requirements.

Responsibilities may include the following and other duties may be assigned.

• Lead investigations into fielded product issues including performing the risk analysis for the issue with a comparison to the risk management files and impacts to existing risk mitigations.

• Identify and initiate change request if risk management files need to be reviewed and updated.

• Collaborate with Medical Safety to review and analyze field data, discuss the harm severity sources, and estimate the probability or harm occurrence.

• Participate in the identification, assessment, and disposition of software anomalies.

• Evaluate reliability impact of proposed design and manufacturing changes on existing market released product. This includes physical hardware changes as well as, embedded firmware, and health software applications.

• Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with a product nonconformance, complaint, design, or manufacturing change.

• Represent the organization as a technical contact for risk and reliability for processes such as: Non conformances, Anomaly Dispositions, Deviations, Complaint Formal Investigations, Change Control and CAPA among others.

Must Have (Minimum Requirements)

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s degree required with a minimum of 4 years of experience in Medical Device or related industry

• OR advance degree with a minimum of 2 years of experience in Medical Device or related industry experience

Nice to Have (Preferred Qualifications)

• Ability to lead cross-functional teams and drive discussion and decision-making.  This includes facilitation, consensus building and conflict resolution.

• Experience in Medical devices – specifically in Neuromodulation/Pelvic Health devices is preferred

• Strong analytical skills and the ability to solve problems through analytical reasoning.

• Experience with Software Application or Embedded Software development and testing.

• Experience in medical devices or other highly regulated industry such as defense or automotive.

• Experience in quality, reliability, design assurance, safety, or systems engineering.

• Experience with and knowledge of medical device standards including ISO 13485, ISO 14971 (risk management.).

• Formal training in quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.)

• ASQ Certification in Quality or Reliability is a plus.

• Experience in the design, maintenance, or continuation engineering of software or software systems, including mobile applications is a plus.

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.

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.
 

Salary ranges for U.S (excl. PR) locations (USD):$101,600 - $152,400

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).

The following benefits and additional compensation are available to all regular employees: 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.

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 90,000+ 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.