We anticipate the application window for this opening will close on - 18 Nov 2025

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

The Principal Hardware Engineer 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. Represent the organization as the prime technical contact on contracts and projects.

You will be required to work on-site at one of our regional site locations: California and Colorado/ Minnesota locations four (4) days per week. This on-site presence is crucial to fostering collaboration and maintaining a strong connection with our team and the workplace environment.

A Day in the Life:
Interact with personnel on significant technical matters often requiring coordination between organizations
Identifies and oversees 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 (CIFs)
Initiates change activity (CA) to modify maintain design documentation (BOMs Specs drawings)
Supports CAPAs (Corrective & Preventive Actions) and RPIs (Released Product Investigations) including possible CAPA ownership
Provides RPE input to new product development teams
Assists Regulatory Specialists by providing design & clinical use data and rationale to support worldwide regulatory submissions and certification renewals.
Supports IQ/OQ/PQ DOEs SPC Gauge R&R Sampling methodologies Data Analysis Hypothesis Testing Modeling/Predictive Analyses Capability Studies (CpK) and Component Qualifications
Collaborates with reliability and manufacturing personnel to determine and execute appropriate tests/assessments to evaluate supplier process material design or component changes prior to implementation
Collaborates 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)
Assists manufacturing sites with lean layout initiatives interfacility transfers and outsourcing
Supports cost reduction and continuous improvement projects
Provides problem solving/trouble shooting support to manufacturing sites and key suppliers to increase yields maintain process capability and improve efficiency and cost
Supports internal and external regulatory compliance audits
Actively participates in new product development to RPE transfers; ensures completion of all transfer deliverables

The key job responsibilities of the Principal Hardware Engineer are as follows:

• Proficient knowledge of CRM devices (ICDs IPGs 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
• Demonstrates good judgment pertaining to issue escalation and consultation with other SMEs
• Able to work independently and exercise appropriate latitude when addressing abstract yet to be defined technical issues and problems
• Results focused. Able to deliver consistent high quality work to meet product performance compliance schedule and budget requirements
• Able to provide solutions to a variety of technical problems of challenging scope and complexity
• Possesses working knowledge of statistical and data analysis tools. SPC DOE Gauge R&R CpK
• Demonstrates clear factual and effective oral and written communication with variety of cross functional colleagues technical peers and senior-level management
• Able to facilitate cross functional group problem solving decision making and small projects; including CAPAs
• Able to effectively prioritize and work on multiple assignments in parallel while keeping stakeholders updated
• Able to work independently follow established procedures and give/receive technical peer reviews of work deliverables for accuracy of technical content

Must Have: Minimum Requirements: To be considered for this role please ensure the minimum requirements are evident on your resume.

• Bachelors degree in Engineering Business or a related field.
• Minimum of 7 years of relevant experience OR Masters degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience

Nice to Have:

• Excellent time management skills with ability to manage multiple priorities and deliver on time
• Solid leadership and interpersonal skills including ability to effectively formulate and convey technical and cost/benefit/risk information with peers and senior leaders
• Strong verbal and written communication skills including ability to articulate complex ideas in easy to understand terms
• Working knowledge of Quality System Regulation (QSR 21 CFR 820) EU Medical Device Directive and ISO (13485:2003)
• Knowledge of 6 Sigma (DFSS) principles
• Able to work well under pressure and maintain positive engaged and enthusiastic attitude

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).

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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

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 benefitshere.

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 experiencecertification/education market conditions location etc.

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):$134400.00 - $201600.00

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 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.