Principal Electrical Engineer

$134,400 - $201,600/Yr

Medtronic - Mounds View, MN

Full-time - Principal

Mounds View, MN

Miscellaneous Manufacturing

About the position

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. The engineer will represent the organization as the prime technical contact on contracts and projects, ensuring that all technical matters are addressed effectively and efficiently. In this position, the engineer will interact with personnel on significant technical matters, often requiring coordination between organizations. They will identify and oversee testing required to obtain necessary data to support field actions, regulatory renewals, submissions, and deficiency responses. A critical evaluation of device design will be necessary when representing design in the review of Change Impact Forms (CIF's). The engineer will initiate change activity (CA) to modify and maintain design documentation, including Bills of Materials (BOM's), specifications, and drawings. The Principal Electrical Engineer will support Corrective & Preventive Actions (CAPA's) and Released Product Investigations (RPI's), including possible CAPA ownership. They will provide input to new product development teams and assist Regulatory Specialists by providing design and clinical use data to support worldwide regulatory submissions and certification renewals. The role also includes supporting various methodologies such as IQ/OQ/PQ, Design of Experiments (DOE's), Statistical Process Control (SPC), Gauge R&R, and Capability Studies (CpK). Collaboration with reliability and manufacturing personnel is essential to determine and execute appropriate tests and assessments to evaluate supplier, process, material, design, or component changes prior to implementation. The engineer will also investigate product performance issues and returned product analysis to identify root causes and implement corrective actions. Additionally, they will assist manufacturing sites with lean layout initiatives, interfacility transfers, and outsourcing, while supporting cost reduction and continuous improvement projects. The role requires providing problem-solving and troubleshooting support to manufacturing sites and key suppliers to increase yields, maintain process capability, and improve efficiency and cost. Finally, the engineer will actively participate in new product development to RPE transfers, ensuring completion of all transfer deliverables.

Responsibilities

• Lead device electrical hardware design for implantable cardiac devices.
• Collaborate with cross-functional partners to evaluate and implement design changes.
• Act as the prime technical contact on contracts and projects.
• Identify and oversee testing required for field actions and regulatory submissions.
• Provide critical evaluation of device design in Change Impact Forms (CIF's) review.
• Initiate change activity to modify and maintain design documentation.
• Support CAPA's and RPI's, including possible CAPA ownership.
• Provide input to new product development teams.
• Assist Regulatory Specialists with design and clinical use data for regulatory submissions.
• Support various methodologies including IQ/OQ/PQ, DOE's, SPC, and Capability Studies.
• Collaborate with reliability and manufacturing personnel for testing and assessments.
• Investigate product performance issues and implement corrective actions.
• Assist manufacturing sites with lean layout initiatives and outsourcing.
• Support cost reduction and continuous improvement projects.
• Provide troubleshooting support to manufacturing sites and suppliers.
• Participate in new product development to RPE transfers.

Requirements

• Requires a Baccalaureate degree in Electrical or Biomedical Engineering or equivalent.
• Minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
• Solid leadership and interpersonal skills.
• Strong verbal and written communication skills.
• Working knowledge of Quality System Regulation (QSR 21 CFR 820) and ISO (13485:2003).
• Knowledge of 6 Sigma (DFSS) principles.
• Proficient knowledge of CRM devices (ICD's, IPG's, CRT-D/P, ICM).
• Basic knowledge of device hardware processes and electrical components.
• Demonstrates good judgment in issue escalation and consultation with other SMEs.
• Able to work independently and address abstract technical issues.

Nice-to-haves

• MS in Electrical or Biomedical Engineering.
• Excellent time management skills.
• Strong ability to convey technical and cost/benefit/risk information.
• Working knowledge of medical device industry standards and regulations.
• Demonstrates clear and effective communication with cross-functional colleagues.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive through the Medtronic Incentive Plan (MIP).
• Wide range of benefits and resources to support employees at every career and life stage.