Principal Mechanical Design Engineer

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 la ... (truncated, view full listing at source)