Hybrid Principal Electrical Engineer

at Medtronic

• Job title: Principal Electrical Engineer
• Job type: Full Time
• Experience level: Lead
• Salary: $134,400 - $201,600 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Mounds View, United States

About the role

• Principal Electrical Engineer responsible for technical and mechanical design of implantable cardiac devices. Collaborating with cross-functional teams, ensuring compliance and driving innovation at Medtronic.

Responsibilities

• Lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
• Responsible for technical and mechanical design leadership for market-released implantable cardiac devices.
• Collaborate 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.
• 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 and 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.

Requirements

• Bachelor’s degree in Engineering, Business, or a related field.
• Minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience
• 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
• 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 independently, follow established procedures, and give/receive technical peer reviews of work deliverables for accuracy of technical content.

Benefits

• 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)