Job Summary
As part of a $70M+ manufacturer of surgical solutions for the medical industry, the Senior Electrical Engineer is a senior-level technical leader responsible for both sustaining production and leading complex electrical and electromechanical projects. This role owns system-level electrical performance across manufacturing, test, field issues, and product changes. The position requires the ability to independently lead projects, mentor engineers and technicians, and resolve daily production issues without close supervision. The Senior Electrical Engineer is expected to balance strategic project execution with hands-on troubleshooting, ensuring safe, compliant, and reliable operation of electrical subsystems in a regulated medical device environment.
Essential Job Duties and Responsibilities
- Serve as the technical owner for electrical and electromechanical systems, including PCBAs, sensors, test systems, and software-controlled subsystems.
- Independently lead medium-to-large cross-functional projects, defining scope, schedules, risks, and deliverables, and driving execution through completion.
- Provide day-to-day engineering support to production by responding to electrical failures, test issues, yield losses, and line stoppages with urgency.
- Troubleshoot electrical and electronic issues down to the component level using schematics, BOMs, and test data; utilize oscilloscopes, logic analyzers, multimeters, and other diagnostic tools as required.
- Support root cause investigations for production, supplier, and field failures; implement robust corrective actions and ensure effectiveness.
- Own and execute electrical engineering change orders (ECOs), including impact assessment, documentation, validation support, and implementation.
- Lead design changes and sustaining engineering activities by translating requirements into electrical design updates, test strategies, and manufacturing outputs.
- Support and lead validation and qualification activities (IQ/OQ/PQ/PPQ) for electrical test equipment, fixtures, and product changes.
- Develop, review, and approve electrical test methods, LabVIEW-based or equivalent automated test systems, and in-circuit test strategies.
- Partner with Quality, Operations, Supply Chain, and Field Service to resolve non-conformances, complaints, and recurring electrical issues.
- Interface directly with electrical and electromechanical suppliers to investigate failures, improve designs, and support component qualification.
- Analyze production and field data to identify trends, risks, and improvement opportunities; communicate findings through clear technical reports.
- Mentor and provide technical guidance to Engineers I and II, technicians, and cross-functional team members.
- Participate in design reviews for NPI and sustaining products, providing design-for-manufacturing, testability, and serviceability input.
- Ensure compliance with FDA QSR, ISO 13485, ISO 14971, and internal quality system procedures.
- Apply structured problem-solving tools such as FMEA, Fault Tree, A3, and statistical analysis to improve reliability and reduce variability.
- Support continuous improvement initiatives aligned with NBS Next, including standard work, problem-solving culture, and waste reduction.
Education and Experience Requirements
- Bachelor’s degree in Electrical Engineering, Systems Engineering, Mechatronics, or a related discipline required.
- Master’s degree preferred.
- Minimum of 8–10 years of experience in electrical or electromechanical engineering within a manufacturing or regulated environment.
- Medical device experience strongly preferred.
- Demonstrated experience leading projects independently while supporting active production lines.
Required Skills and Abilities
- Strong system-level understanding of electrical and electromechanical devices.
- Proven ability to lead projects and technical teams without direct supervision.
- Advanced troubleshooting skills at the board, subsystem, and system level.
- Ability to balance long-term project work with urgent production support.
- Experience with ECAD tools (Altium, OrCAD, PADS, or equivalent).
- Proficiency with electrical test equipment and automated test systems.
- Strong technical writing and communication skills, including reports, validations, and ECO documentation.
- Comfortable working cross-functionally and communicating complex issues to non-technical stakeholders.
Working Conditions and Physical Demands
PHYSICAL DEMANDS:
The characteristics listed below are representative of the physical demands required by an individual to successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
- May be required to sit, stand, or bend for extended periods.
- Regular use of a computer and communication tools.
- May require travel up to 10% to supplier or manufacturing sites.
WORK ENVIRONMENT:
The characteristics listed below are representative of the work environment typically encountered by an individual while performing the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
- Lab and production floor environments; may require use of ESD precautions.
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