Principal Electrical Engineer

12-month contract with potential for extension, located in Plymouth, MN. W2 contract; no PTO or benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and able to sit on Primary Talent Partners W2 without sponsorship. Minimum 4 days per week onsite.

About the role

We bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. As a Principal Electrical Engineer, you will serve as a recognized technical expert and engineering leader within the Released Product Engineering (RPE) organization supporting our client’s Surgical Hardware portfolio. This role leads complex electrical engineering activities across sustaining engineering, product enhancements, quality investigations, regulatory compliance, cost optimization, supplier changes, and lifecycle management initiatives.

Responsibilities

• Serve as the electrical engineering subject matter expert for complex sustaining engineering, quality, compliance, and product enhancement initiatives.
• Lead the design, development, integration, verification, and validation of mixed-signal electrical systems and subsystems used in surgical medical devices.
• Define hardware architectures and technical solutions that balance product performance, reliability, manufacturability, compliance, and cost objectives.
• Review and approve electrical designs, schematics, test plans, engineering changes, and qualification strategies.
• Drive system-level troubleshooting and root cause investigations involving electrical, mechanical, software, and firmware interactions.
• Lead electrical engineering activities supporting released products, including:
  • Design changes and engineering change orders (ECOs)
  • Obsolescence management
  • Supplier-driven changes
  • Lifecycle and End-of-Life (EOL) initiatives
  • Cost reduction and VAVE projects
  • Manufacturing and field quality improvements
• Assess product impacts associated with component, material, and supplier changes and determine requalification requirements.
• Support manufacturing and supplier quality teams in resolving production issues and field-related concerns.
• Ensure designs comply with applicable standards and regulations, including:
  • IEC 60601-1
  • IEC 60601-1-2
  • IEC 60601-2-2
  • FDA Quality System Requirements
  • ISO 13485
  • Risk Management requirements
• Lead technical assessments and investigations related to customer complaints, CAPAs, nonconformances, audits, and field performance issues.
• Evaluate complaint trends and reliability data to determine if systemic quality issues exist and develop appropriate corrective actions.
• Support EMC, electrical safety, environmental, reliability, and performance testing activities.
• Perform and oversee:
  • Circuit design
  • Schematic capture
  • PCB layout reviews
  • Component selection
  • Design analysis and simulation
  • System integration
  • Design verification testing
• Develop detailed technical specifications, requirements, test protocols, and engineering documentation.
• Ensure hardware designs meet performance, reliability, safety, and manufacturability requirements.
• Partner with Systems Engineering, Software, Firmware, Mechanical, Quality, Regulatory Affairs, Operations, Supply Chain, and Manufacturing Engineering teams.
• Work with external test laboratories, suppliers, consultants, and contract manufacturers as required.
• Provide technical leadership during cross-functional design reviews, risk reviews, and business decision-making processes.
• Identify opportunities to improve product performance, reliability, compliance, manufacturability, and cost.
• Drive adoption of engineering best practices, tools, and methodologies.
• Support platform strategies, design standardization, and technology roadmaps across the Surgical Hardware portfolio.
• Contribute to the evaluation and implementation of emerging technologies.
• Mentor and coach electrical engineers and cross-functional team members.
• Lead technical reviews and provide guidance on engineering approaches and problem-solving techniques.
• Influence technical direction across multiple projects and product platforms.
• Serve as a technical leader for major cross-functional initiatives and strategic engineering projects.

Requirements

• Bachelor’s degree in Electrical Engineering or related engineering discipline with 7+ years of relevant experience OR Master’s degree with 5+ years of relevant experience.
• Experience with all phases of mixed-signal board design, including:
  • Architecture development
  • Circuit design
  • Schematic capture
  • Component selection
  • PCB layout and reviews
  • Design verification
• Strong fundamentals in:
  • Analog and digital circuit design
  • Signals and systems
  • Frequency-domain analysis
  • Power electronics
  • System integration
• Experience with OrCAD schematic capture and PCB design tools.
• Hands-on experience using laboratory equipment including:
  • Oscilloscopes
  • Multimeters
  • Logic analyzers
  • Spectrum analyzers
  • Network analyzers
• Experience designing, testing, and troubleshooting high-voltage systems (up to approximately 5 kV).
• Experience working within regulated industries, preferably medical devices.
• Knowledge of IEC 60601 family of standards and medical device development processes.
• Strong root-cause analysis and structured problem-solving skills.
• Excellent written, verbal, and presentation communication skills.

Preferred Qualifications

• Experience supporting released products within a medical device environment.
• Experience with EMC and electrical safety testing.
• Experience with supplier qualification, supplier-driven changes, and component obsolescence management.
• Experience leading VAVE and cost optimization initiatives.
• Exposure to systems engineering practices and requirements-driven development.
• Experience working in Agile product development environments.
• Familiarity with Surgical Hardware or electrosurgical products.
• Lean, Six Sigma, or A3 problem-solving experience.
• Demonstrated ability to influence technical decisions across organizations.

Top 3 Skill Sets Required

1. Mixed-Signal Electrical Design and Hardware Development
   • Analog and digital circuit design
   • Power electronics and high-voltage systems
   • Schematic capture, PCB layout reviews, component selection, and design verification
   • OrCAD and laboratory equipment experience
   • 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 assessment and requalification decisions
   • Complaint investigations, CAPA, nonconformances, and field-performance issues
   • Knowledge of IEC 60601 standards, ISO 13485, FDA requirements, and design controls
3. System-Level Technical Leadership and Cross-Functional Influence
   • Root-cause analysis across electrical, mechanical, firmware, and software domains
   • Requirements-driven development and verification strategy
   • Leadership of technical reviews and complex problem-solving
   • Effective collaboration with quality, regulatory, manufacturing, suppliers, and operations
   • Mentoring engineers and influencing technical direction without direct authority

Day-to-Day Responsibilities

1. Resolve Product Quality, Field, and Manufacturing Issues
   • Lead electrical and system-level troubleshooting.
   • Investigate complaints, CAPAs, nonconformances, and reliability concerns.
   • Perform root-cause analysis with firmware, software, mechanical, quality, and manufacturing teams.
   • Define corrective actions and support verification of their effectiveness.
2. Lead Sustaining Engineering and Product Lifecycle Activities
   • Own ECOs, component obsolescence, supplier changes, EOL activities, and VAVE projects.
   • Assess product impact, risks, and qualification or validation needs.
   • Support supplier and manufacturing issue resolution.
   • Maintain product performance, compliance, cost, and supply continuity throughout the lifecycle.
3. Provide Electrical Design and Technical Leadership
   • Review schematics, PCB layouts, test protocols, qualification plans, and engineering changes.
   • Support mixed-signal circuit design, system integration, verification, EMC, and electrical-safety activities.
   • Lead technical reviews and mentor engineers.
   • Influence decisions across systems, firmware, software, mechanical, quality, regulatory, suppliers, and operations.

Pay

$60.00 - $70.00/hr

Schedule

Minimum 4 days per week onsite