R-
Sr Electrical Engineer (W2)
Accepting applicationsRedbock - an NES Fircroft company · Plymouth, MA
Contract Mid_senior Mentoranalogmixed-signal
Posted
3d ago
Category
Verification
Experience
Mid_senior
Country
United States
Principal Electrical Engineer – Released Product Engineering
Position Summary
The Principal Electrical Engineer will serve as a technical lead supporting released surgical hardware products throughout their lifecycle. This role will lead complex electrical engineering efforts involving sustaining engineering, product improvements, quality investigations, supplier and component changes, regulatory compliance, cost reduction, and obsolescence management.
The ideal candidate will have strong hands-on experience with mixed-signal electronics, board-level design, system integration, troubleshooting, and regulated medical device development, along with the ability to lead cross-functional technical initiatives.
Key Responsibilities
Serve as the electrical engineering SME for sustaining engineering, quality, compliance, and product improvement projects.
Lead mixed-signal electrical design, integration, verification, and validation activities.
Review and approve schematics, PCB designs, test plans, engineering changes, and qualification strategies.
Lead system-level troubleshooting and root-cause investigations involving hardware, firmware, software, and mechanical interfaces.
Support released product changes including ECOs, component obsolescence, supplier changes, EOL activities, VAVE/cost reduction, and manufacturing improvements.
Assess component and supplier changes and determine appropriate testing or requalification requirements.
Support CAPAs, nonconformances, complaints, field issues, and reliability investigations.
Ensure compliance with applicable medical device standards, including IEC 60601, FDA Quality System requirements, ISO 13485, and risk management requirements.
Support EMC, electrical safety, reliability, environmental, and performance testing.
Partner closely with Systems, Software, Firmware, Mechanical, Quality, Regulatory, Manufacturing, Supply Chain, and Supplier Quality teams.
Mentor engineers and provide technical leadership across projects and product platforms.
Required Experience
Extensive experience with mixed-signal board design, including architecture, analog/digital circuit design, schematic capture, component selection, PCB layout/review, and design verification.
Strong understanding of signals and systems, frequency-domain analysis, power electronics, and system integration.
Experience with OrCAD or comparable schematic/PCB design tools.
Hands-on laboratory troubleshooting using oscilloscopes, multimeters, logic analyzers, spectrum analyzers, and related equipment.
Experience designing and troubleshooting high-voltage systems up to approximately 5 kV.
Experience working in a regulated industry; medical device experience strongly preferred.
Knowledge of the IEC 60601 family of standards and medical device development processes.
Strong root-cause analysis, technical problem-solving, documentation, and communication skills.
Preferred Experience
Released product/sustaining engineering within medical devices.
EMC and electrical safety testing.
Supplier changes, supplier qualification, and component obsolescence management.
VAVE or cost-reduction initiatives.
Systems engineering and requirements-driven development.
Surgical hardware or electrosurgical product experience.
Agile, Lean, Six Sigma, or A3 problem-solving experience.
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Position Summary
The Principal Electrical Engineer will serve as a technical lead supporting released surgical hardware products throughout their lifecycle. This role will lead complex electrical engineering efforts involving sustaining engineering, product improvements, quality investigations, supplier and component changes, regulatory compliance, cost reduction, and obsolescence management.
The ideal candidate will have strong hands-on experience with mixed-signal electronics, board-level design, system integration, troubleshooting, and regulated medical device development, along with the ability to lead cross-functional technical initiatives.
Key Responsibilities
Serve as the electrical engineering SME for sustaining engineering, quality, compliance, and product improvement projects.
Lead mixed-signal electrical design, integration, verification, and validation activities.
Review and approve schematics, PCB designs, test plans, engineering changes, and qualification strategies.
Lead system-level troubleshooting and root-cause investigations involving hardware, firmware, software, and mechanical interfaces.
Support released product changes including ECOs, component obsolescence, supplier changes, EOL activities, VAVE/cost reduction, and manufacturing improvements.
Assess component and supplier changes and determine appropriate testing or requalification requirements.
Support CAPAs, nonconformances, complaints, field issues, and reliability investigations.
Ensure compliance with applicable medical device standards, including IEC 60601, FDA Quality System requirements, ISO 13485, and risk management requirements.
Support EMC, electrical safety, reliability, environmental, and performance testing.
Partner closely with Systems, Software, Firmware, Mechanical, Quality, Regulatory, Manufacturing, Supply Chain, and Supplier Quality teams.
Mentor engineers and provide technical leadership across projects and product platforms.
Required Experience
Extensive experience with mixed-signal board design, including architecture, analog/digital circuit design, schematic capture, component selection, PCB layout/review, and design verification.
Strong understanding of signals and systems, frequency-domain analysis, power electronics, and system integration.
Experience with OrCAD or comparable schematic/PCB design tools.
Hands-on laboratory troubleshooting using oscilloscopes, multimeters, logic analyzers, spectrum analyzers, and related equipment.
Experience designing and troubleshooting high-voltage systems up to approximately 5 kV.
Experience working in a regulated industry; medical device experience strongly preferred.
Knowledge of the IEC 60601 family of standards and medical device development processes.
Strong root-cause analysis, technical problem-solving, documentation, and communication skills.
Preferred Experience
Released product/sustaining engineering within medical devices.
EMC and electrical safety testing.
Supplier changes, supplier qualification, and component obsolescence management.
VAVE or cost-reduction initiatives.
Systems engineering and requirements-driven development.
Surgical hardware or electrosurgical product experience.
Agile, Lean, Six Sigma, or A3 problem-solving experience.
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