Medtronic

Medtronic

Principal Mechanical Design Engineer

St Paul, Minnesota, USFull-time5 days agovia Lensa

Salary

-

Job type

Full-time

Location

St Paul, Minnesota, US

Remote

No

Posted

5 days ago

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Job description

We anticipate the application window for this opening will close on - 9 Apr 2026

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

The Principal Mechanical Design Engineer for Medtronic CRM RPE will be responsible for technical and mechanical design leadership for market-released implantable cardiac devices. This role involves collaboration with cross-functional partners such as reliability, regulatory, operations, and sourcing colleagues to evaluate and implement design changes. This role represents the organization as the prime technical contact on contracts and projects.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working onsite a minimum of 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.

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

  • Interact with personnel on significant technical matters often requiring coordination between organizations
  • Identify and oversee testing required to obtain necessary data to support field actions, regulatory renewals, submissions and deficiency responses
  • Provide critical evaluation of device design when representing design in review of Change Impact Forms (CIF's)
  • Initiate change activity (CA) to modify maintain design documentation (BOM's, Specs, drawings)
  • Support CAPA's (Corrective & Preventive Actions) and RPI's (Released Product Investigations) including possible CAPA ownership
  • Provide RPE input to new product development teams
  • Assist Regulatory Specialists by providing design & clinical use data and rationale to support worldwide regulatory submissions and certification renewals
  • Support IQ/OQ/PQ, DOE's, SPC, Gauge R&R, Sampling methodologies, Data Analysis, Hypothesis Testing, Modeling/Predictive Analyses, Capability Studies (CpK) and Component Qualifications
  • Collaborate with reliability and manufacturing personnel to determine and execute appropriate tests/assessments to evaluate supplier, process, material, design, or component changes prior to implementation
  • Collaborate with reliability, manufacturing, materials, and R&D to investigate product performance issues/returned product analysis to identify root cause(s) and implement corrective action(s)
  • Assist manufacturing sites with lean layout initiatives, interfacility transfers and outsourcing
  • Support cost reduction and continuous improvement projects
  • Provide problem solving/trouble shooting support to manufacturing sites and key suppliers to increase yields, maintain process capability, and improve efficiency and cost
  • Support internal and external regulatory compliance audits
  • Actively participate in new product development to RPE transfers; ensure completion of all transfer deliverables

Nice to Haves

  • MS in Mechanical or Biomedical Engineering
  • High proficiency of using internal systems such as Windchill, MAP Agile, CATS, and Documentum
  • Familiarity with CAD systems such as Creo and SolidWorks
  • Solid leadership and interpersonal skills including ability to effectively formulate and convey technical and cost/benefit/risk information with peers and senior leaders
  • Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive, and ISO (13485:2003)
  • Knowledge of 6 Sigma (DFSS) principles

Must Haves

  • Proficient knowledge of CRM devices (ICD's, IPG's, CRT-D/P, ICM)
  • Working level understanding of CRM product implant procedures, clinical use conditions, new indications, competitive product landscape & state of the art industry status
  • Proficient knowledge of medical device industry standards, regulations compliance requirements
  • Basic knowledge of mechanical processes, materials, processes, PFMEA and DFMEA
  • Working knowledge of statistical and data analysis tools: SPC, DOE, Gauge R&R, CpK
  • Ability to facilitate cross functional group problem solving, decision making, and small projects; including CAPA's
  • Bachelor's Degree in Mechanical or Biomedical Engineering
  • 7+ years of Medical Device Industry Experience

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):$128,000.00 - $192,000.00

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. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

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 (http://www.medtronic.com) .

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 (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) 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.

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.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will...

  • Build a better future, amplifying your impact on the causes that matter to you and the world
  • Grow a career reflective of your passion and abilities
  • Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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.

For sales reps and other patient facing field employees, going into a healthcare setting?is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

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, please click here (https://www.e-verify.gov/employees) .

For updates on job applications, please go to the candidate login page and sign in to check your application status.

If you need assistance completing your application please email AskHR@medtronic.com

To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com

Responsibilities

  • The Principal Mechanical Design Engineer for Medtronic CRM RPE will be responsible for technical and mechanical design leadership for market-released implantable cardiac devices
  • This role involves collaboration with cross-functional partners such as reliability, regulatory, operations, and sourcing colleagues to evaluate and implement design changes
  • This role represents the organization as the prime technical contact on contracts and projects
  • This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects
  • Interact with personnel on significant technical matters often requiring coordination between organizations
  • Identify and oversee testing required to obtain necessary data to support field actions, regulatory renewals, submissions and deficiency responses
  • Provide critical evaluation of device design when representing design in review of Change Impact Forms (CIF's)
  • Initiate change activity (CA) to modify maintain design documentation (BOM's, Specs, drawings)
  • Support CAPA's (Corrective & Preventive Actions) and RPI's (Released Product Investigations) including possible CAPA ownership
  • Provide RPE input to new product development teams
  • Assist Regulatory Specialists by providing design & clinical use data and rationale to support worldwide regulatory submissions and certification renewals
  • Support IQ/OQ/PQ, DOE's, SPC, Gauge R&R, Sampling methodologies, Data Analysis, Hypothesis Testing, Modeling/Predictive Analyses, Capability Studies (CpK) and Component Qualifications
  • Collaborate with reliability and manufacturing personnel to determine and execute appropriate tests/assessments to evaluate supplier, process, material, design, or component changes prior to implementation
  • Collaborate with reliability, manufacturing, materials, and R&D to investigate product performance issues/returned product analysis to identify root cause(s) and implement corrective action(s)
  • Assist manufacturing sites with lean layout initiatives, interfacility transfers and outsourcing
  • Support cost reduction and continuous improvement projects
  • Provide problem solving/trouble shooting support to manufacturing sites and key suppliers to increase yields, maintain process capability, and improve efficiency and cost
  • Support internal and external regulatory compliance audits
  • Actively participate in new product development to RPE transfers; ensure completion of all transfer deliverables
  • 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
  • Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

Qualifications

  • MS in Mechanical or Biomedical Engineering
  • High proficiency of using internal systems such as Windchill, MAP Agile, CATS, and Documentum
  • Familiarity with CAD systems such as Creo and SolidWorks
  • Solid leadership and interpersonal skills including ability to effectively formulate and convey technical and cost/benefit/risk information with peers and senior leaders
  • Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive, and ISO (13485:2003)
  • Knowledge of 6 Sigma (DFSS) principles
  • Proficient knowledge of CRM devices (ICD's, IPG's, CRT-D/P, ICM)
  • Working level understanding of CRM product implant procedures, clinical use conditions, new indications, competitive product landscape & state of the art industry status
  • Proficient knowledge of medical device industry standards, regulations compliance requirements
  • Basic knowledge of mechanical processes, materials, processes, PFMEA and DFMEA
  • Working knowledge of statistical and data analysis tools: SPC, DOE, Gauge R&R, CpK
  • Ability to facilitate cross functional group problem solving, decision making, and small projects; including CAPA's
  • Bachelor's Degree in Mechanical or Biomedical Engineering
  • 7+ years of Medical Device Industry Experience
  • 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
  • U.S. Work Authorization & Sponsorship

Benefits

  • Benefits & Compensation
  • Medtronic offers a competitive Salary and flexible Benefits Package
  • A commitment to our employees lives at the core of our values
  • 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):$128,000.00 - $192,000.00
  • 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
  • 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
  • Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

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