Medtronic

Sr. Engineering Manager, Premarket Risk and Reliability, Mounds View, MN

Medtronic  •  $257k/yr  •  United States (Onsite)  •  6 hours ago
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Job Description

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 Life

Medtronic leads the health care industry to provide solutions that benefit the daily lives of people across the globe. Our organization contributes directly to this mission through product risk management and reliability engineering for implantable cardiac rhythm products. Striving for unsurpassed quality and reliability in our products is part of our Medtronic mission, and this team is focused on making that a reality in our product development efforts. Become part of our team and you will be challenged to play a leadership role in building a high performing team, designing and launching lifesaving technologies, and be able to make a real difference.

As a Sr. Design Engineering Manager, you will lead the Premarket Reliability and Safety team focused on Medtronic’s Cardiac Rhythm Management Portfolio, you will be asked to manage and guide the Risk and Reliability engineers in the pre-market design space. You will be responsible to drive development of safe, reliable, and compliant products/systems while working very closely with the cross functional teams and building a highly technical and competitive design quality engineers.

The best candidates will be critical thinkers, problem solvers, strong executers, self-driven with strong leadership skills & hands-on management approach. Strong relationship skills are a must, as is excellent verbal and written communication.

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

  • Plans, directs, and implements all quality aspects of the company's design and development of new implantable medical device products and systems, with detailed focus on reliability, risk management and patient safety.
  • Provide oversight and training in the application of work processes to ensure successful adoption by development teams and positive, measurable results obtained from development programs.
  • Work closely with cross functional teams and quality peers to ensure project planning is complete end-to-end, for both pre-market and post-market activities.
  • Manages activities to assure programs are appropriately resourced and ensure continuous improvement in technical capability, process, and compliance.
  • Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Communicate program status using clear metrics and specific actions plans, applying organizational acumen appropriate for a senior level audience.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
  • Manages feasibility studies of the design to determine if capable of functioning as intended.
  • Selects, develops and evaluates personnel to ensure the efficient operation of the function.

Must Have: Minimum Requirements- To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

  • Bachelor’s degree required in Engineering, Science or technical field with 7+ years of experience in the medical device engineering space and 5 years of technical leadership or managerial experience. OR Advanced Degree in Engineering, Science or technical field with 5+ years of experience in the medical device engineering space and 5 years of technical leadership or managerial experience.

Nice to Have

  • Direct experience in mechanical design, risk management, reliability, or systems engineering in a design engineering role.
  • Extensive experience in complex product development projects with strong knowledge of product development in regulated industries (such as medical device, healthcare, aerospace, or transportation industries)
  • Working knowledge of 21 CFR 820.30 and ISO 14971
  • Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, and MDD/EU MDR.
  • Ability to author technical reports, business correspondence and standard operating procedures.
  • Experience in applying metrics to measure and improve processes and product quality during product development.
  • Proven track record of success in leading cross functional efforts in work process improvement.
  • Experience in influencing, educating, and fostering others in adopting work practices.
  • Strong employment history of assuming successive organizational roles with increasing responsibility.

Physical Job Requirements:

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. (ADA-United States of America).

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. Learn more about our benefits here

In addition to Base Salary, this position is eligible for a short-term incentive plan, which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. Learn more about Medtronic Incentive Plan (MIP) here

The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc. ​

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.

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 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 & 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):$171,200.00 - $256,800.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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, 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 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), 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 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.

Medtronic

About Medtronic

A global healthcare technology leader — boldly attacking the most challenging health problems facing humanity with innovations that transform lives.

Industry
Manufacturing & Production
Company Size
10,000+ employees
Headquarters
Minneapolis, MN
Year Founded
Unknown
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