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 Electrical Engineer for Medtronic CRM RPE will be responsible for device electrical hardware 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.

•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 (CIF’s) 
•Initiates change activity (CA) to modify maintain design documentation (BOM’s, Specs, drawings)
•Supports CAPA’s (Corrective & Preventive Actions) and RPI’s (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, DOE’s, 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 New Product Development 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

Nice to Have:

• MS in Electrical or Biomedical Engineering
• 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
• 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 device hardware processes, device electrical components, processes, PFMEA and DFMEA
• Demonstrates good judgment pertaining to issue escalation and consultation with other SME’s
• 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 CAPA’s
• Able to effectively prioritize and work on multiple assignments in parallel while keeping stakeholders updated
• Able to work inde