We are seeking an experienced Principal Electrical Engineer to support Released Product Engineering (RPE) for a surgical medical device portfolio in Plymouth, MN.
This role is ideal for a senior electrical engineering professional with strong expertise in mixed-signal electronics, hardware development, system integration, sustaining engineering, and regulated medical device products.
The Principal Electrical Engineer will serve as a technical expert and engineering leader, driving complex product quality investigations, lifecycle engineering activities, electrical design reviews, product enhancements, regulatory compliance, cost optimization, and supplier-related changes.
You will work closely with Electrical, Systems, Mechanical, Firmware, Software, Quality, Regulatory, Manufacturing, Supplier Quality, Supply Chain, and Operations teams.
Key Responsibilities
1. Product Quality, Field & Manufacturing Support
- Lead electrical and system-level troubleshooting of complex product issues.
- Investigate customer complaints, CAPAs, nonconformances, reliability concerns, and field-performance issues.
- Perform root-cause analysis across electrical, mechanical, firmware, software, and systems domains.
- Define corrective and preventive actions and support verification of their effectiveness.
- Partner with manufacturing and supplier quality teams to resolve production and field issues.
2. Sustaining Engineering & Product Lifecycle Management
- Lead engineering activities for released products throughout the product lifecycle.
- Own and support Engineering Change Orders (ECOs), component obsolescence, supplier changes, EOL activities, and VAVE/cost-reduction projects.
- Assess product, component, material, and supplier changes for technical and regulatory impact.
- Determine appropriate qualification, validation, and requalification requirements.
- Support supplier and manufacturing issue resolution while maintaining product performance, compliance, cost, and supply continuity.
3. Electrical Design & Technical Leadership
- Lead and review mixed-signal electrical design activities.
- Review schematics, PCB layouts, component selections, test protocols, qualification plans, and engineering changes.
- Support circuit design, system integration, design verification, EMC, and electrical safety activities.
- Develop technical requirements, specifications, test strategies, and engineering documentation.
- Lead technical reviews and mentor engineers.
- Influence technical direction across multiple engineering and business functions.
Required Qualifications
- Bachelor’s degree in electrical engineering or a related engineering discipline with 10+ years of relevant experience, OR
- Master’s degree with 8+ years of relevant experience, OR
- PhD with 5+ years of relevant experience.
- Strong experience with mixed-signal board design, including architecture, circuit design, schematic capture, component selection, PCB layout/review, and design verification.
- Strong knowledge of analog and digital circuit design, signals and systems, frequency-domain analysis, power electronics, and system integration.
- Experience with OrCAD schematic capture and PCB design tools.
- Hands‑on experience with laboratory equipment such as oscilloscopes, multimeters, logic analyzers, spectrum analyzers, and network analyzers.
- Experience designing, testing, and troubleshooting high‑voltage systems up to approximately 5 kV.
- Experience working within a regulated industry; medical device experience is strongly preferred.
- Knowledge of IEC 60601 standards, ISO 13485, FDA requirements, risk management, and medical device design controls.
- Strong root‑cause analysis and structured problem‑solving capabilities.
- Excellent written, verbal, presentation, and cross‑functional communication skills.
Preferred Qualifications
- Experience supporting released products in a medical device environment.
- Experience with EMC and electrical safety testing.
- Experience with supplier qualification and supplier‑driven engineering changes.
- Experience managing component obsolescence and EOL activities.
- Experience leading VAVE and cost optimization initiatives.
- Knowledge of systems engineering and requirements‑driven development.
- Experience with surgical hardware or electrosurgical products.
- Lean, Six Sigma, or A3 problem‑solving experience.
- Demonstrated ability to influence technical decisions without direct authority.
Top 3 Skill Sets
1. Mixed‑Signal Electrical Design & Hardware Development
- Analog and digital circuit design
- Power electronics and high‑voltage systems
- Schematic capture and PCB layout reviews
- Component selection and design verification
- OrCAD and laboratory equipment
- System integration and electrical troubleshooting
2. Regulated Medical Device Product Lifecycle Engineering
- Sustaining engineering and released‑product support
- ECOs, obsolescence management, supplier changes, and VAVE
- Risk‑based impact assessments and requalification decisions
- Complaint investigations, CAPAs, and nonconformances
- IEC 60601, ISO 13485, FDA requirements, and design controls
3. System‑Level Technical Leadership
- Root‑cause analysis across electrical, mechanical, firmware, and software
- Requirements‑driven development and verification
- Technical reviews and complex problem solving
- Cross‑functional collaboration
- Engineering mentorship and technical influence