Principal Electrical Engineer

We are seeking a highly skilled Principal Electrical Engineer to lead our device electrical hardware design efforts for implantable cardiac devices. As a key member of our team, you will be responsible for collaborating with cross-functional partners to evaluate and implement design changes, ensuring the highest level of quality and compliance.

• Lead device electrical hardware design efforts for market-released implantable cardiac devices
• Collaborate with 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, 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 (CIFs)
• Initiate change activity (CA) to modify maintain design documentation (BOMs, Specs, drawings)
• Support CAPAs (Corrective & Preventive Actions) and RPIs (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 New Product Development 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

• 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 a positive, engaged, and enthusiastic attitude
• 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, and 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 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 a 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

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.

Medtronic offers a competitive salary and flexible benefits package. A commitment to our employees' lives is 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): $134, $201,600.00

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).

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 90,000+ 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.

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.

At Medtronic, most positions are posted on our career site for 3-7 days.