Principal Mechanical Design Engineer

Medtronic•Mounds View, MN

3d•Onsite

About The Position

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.

Requirements

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.

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

Responsibilities

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

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
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
Simple Steps (global well-being program)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)