Staff Manufacturing Electrical Engineer
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Job Description
Staff Manufacturing Electrical Engineer
Key Role Responsibilities
- Own and lead root-cause investigations for system-level electrical issues originating from manufacturing, field complaints, service activities, MRB dispositions, nonconformances, and sustaining engineering needs.
- Solve electrical systems including power distribution, motor control, sensors, cabling, harnesses, interconnects, controllers, and system-level electronics.
- Coordinate with R&D on system-level electrical changes and ensure proposed solutions are compatible with mechanical, firmware, software, and other system subsystems.
- Drive electrical design changes through appropriate ECO and change-control processes.
- Lead PCB/PCBA-level failure analysis and work with R&D to define and validate schematic, layout, component, and board-level changes required to resolve technical issues.
- Review schematics, PCB layouts, component selections, test, and electronics architecture to find opportunities for reliability, manufacturability, performance, and cost improvements.
- Support PCB/PCBA rework, prototype builds, engineering evaluations, and qualification of board-level design changes.
- Partner with contract manufacturers and suppliers to implement PCB/PCBA rework, prototype builds, component substitutions, and board-level modifications.
- Ensure Design for Manufacturing (DFM) and Design for Test (DFT) considerations are addressed during sustaining design changes.
- Lead electrical and electronics obsolescence-management activities and proactively identify component lifecycle risks.
- Apply Altium, SiliconExpert, or equivalent engineering tools to support PCB design activities, component lifecycle analysis, and alternate component selection.
- Find opportunities to replace obsolete, high-risk, or costly electronic components while maintaining product quality, performance, reliability, and regulatory compliance.
- Support board-level upgrades and modifications intended to improve product performance, reliability, serviceability, supply continuity, or cost.
- Lead or support Risk Management File updates resulting from electrical or electronics design changes.
- Coordinate with R&D and Quality to ensure required risk documentation is updated and continued compliance with applicable electrical safety and EMC standards is maintained, including IEC 60601-1 and IEC 60601-1-2.
- Lead or support CAPA and nonconformance investigations related to system-level electrical and PCB/PCBA issues.
- Drive structured root-cause analysis, corrective actions, effectiveness checks, and investigation closure in alignment with Quality System and regulatory timelines.
- Support manufacturing line-down situations, production escapes, reliability issues, service issues, and field-return investigations.
- Provide hands-on technical guidance during solving, prototype builds, validation, reliability testing, and production implementation.
- Partner closely with Manufacturing, R&D, Quality, Service, Supplier Quality, Operations, and external manufacturing partners to resolve complex electrical issues and maintain production continuity.
- Communicate technical findings, risks, recommendations, status, and implementation plans clearly to technical and nontechnical partners.
- Ensure engineering documentation, investigations, design-change rationale, and supporting records are complete, accurate, traceable, and audit-ready.
- Support continuous improvement initiatives that improve manufacturing readiness, product reliability, test coverage, operational efficiency, and overall product lifecycle performance.
Required Qualifications
- A minimum bachelor's degree or equivalent experience in Electrical Engineering, Electronics Engineering, Computer Engineering, Biomedical Engineering, or a related technical team; advanced degree in a relevant engineering field is preferred.
- Substantial professional experience in electrical engineering, electronics engineering, sustaining engineering, manufacturing engineering, test engineering, or sophisticated electromechanical systems.
- Strong hands-on experience fixing electrical systems and PCB/PCBA electronics.
- Proven ability to perform structured root-cause analysis and translate findings into practical engineering solutions.
- Ability to read, interpret, and modify electrical schematics, wiring diagrams, PCB layouts, component specifications, test procedures, and system architecture documentation.
- 12+ years of experience working in the medical device, healthcare, or life sciences industry.
- Experience working with PCB/PCBA design, failure analysis, board-level debugging, component selection, or sustaining design changes.
- Experience working multi-functionally with R&D, Manufacturing, Quality, Service, suppliers, and contract manufacturers.
- Knowledge of good manufacturing practices and documentation requirements for production processes.
- Strong understanding of engineering change control, validation, documentation control, and Quality System requirements within a regulated environment.
- Strong written and verbal communication skills with the ability to clearly present technical findings and recommendations.
- Demonstrated ability to independently prioritize multiple technical issues and drive activities through closure.
- Demonstrate Credo-based leadership and collaboration.
Preferred Qualifications
- Master's degree, PhD, or equivalent experience in Electrical Engineering, Electronics Engineering, Computer Engineering, Biomedical Engineering, or a related engineering field.
- Experience in control engineering using Programmable Logic Controllers (PLCs) or Microcontroller Units (MCUs) is highly preferred.
- Experience in medical device manufacturing or another highly supervised industry.
- Experience with robotic systems, capital equipment, sophisticated electromechanical systems, manufacturing test equipment, or system-level sustaining engineering.
- Experience with Altium Designer or equivalent PCB design software.
- Experience with SiliconExpert or equivalent component lifecycle and obsolescence-management tools.
- Experience with PCB layout review, board bring-up, debugging, rework, and design modification.
- Experience working with contract manufacturers on PCB/PCBA builds, rework, qualification, and design changes.
- Strong knowledge of DFM and DFT principles.
- Experience with electrical component obsolescence management and alternate component qualification.
- Familiarity with IEC 60601-1 and IEC 60601-1-2 requirements.
- Experience with CAPA, nonconformance investigations, Risk Management Files, ECOs, and design-change processes.
- Knowledge of Quality System, QSIT and FDA guidelines, 21 CFR 820, ISO 13485, ISO 14971, and applicable guidance.
- Familiarity with ETQ, SAP, Agile, Box, Jira, Maximo, Minitab, or similar engineering and quality-system tools.
- Experience supporting NPI, design transfer, reliability testing, sustaining engineering, and manufacturing operations.
- Lean Six Sigma Green Belt, Black Belt, or equivalent continues improvement certification is preferred.
Other
- This role may require up to 10% domestic and/or international travel based on business needs.
- The attendance policy for this role is fully onsite.
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Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability, or other protected status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform crucial job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
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