Senior Sustaining Engineer – Electrical

Responsibilities

• Perform system-level troubleshooting of electro-mechanical and electro-pneumatic systems, including hardware/software interactions.
• Conduct hands-on electrical engineering analysis (analog and digital) and detailed fault isolation to component or subsystem level.
• Lead root cause investigations for field and internal product issues, ensuring clear problem replication and resolution.
• Own and implement design changes (ECOs), driving solutions that improve product reliability, manufacturability, serviceability, and safety.
• Drive corrective and preventive actions (CAPA) and resolve system-level design and production issues.
• Lead and execute process and product changes to address both field failures and internal manufacturing/quality issues.
• Ensure appropriate verification and validation of all design and process changes.
• Collaborate with manufacturing, quality, service, and other engineering functions to resolve complex technical issues.
• Provide technical leadership and oversight for small internal and external teams and actively contribute within cross-functional teams.
• Conduct component research, selection, and qualification, including supplier engagement and technical evaluation.
• Manage component obsolescence, alternate sourcing, and supply chain continuity.
• Develop, improve, and ensure adherence to processes and procedures required for regulatory compliance in a cGMP medical device environment.
• Support complaint investigations, CAPA activities, and design documentation, ensuring traceability and audit readiness.
• Maintain a strong focus on patient safety, product quality, compliance, and customer satisfaction.
• Demonstrate technical ownership and accountability across the full lifecycle from failure identification → root cause → validated solution implementation.

Qualifications

• Education / Experience: Bachelor’s degree in Electrical Engineering or related field (advanced degree preferred); equivalent medical device experience may substitute. 5+ years of experience in complex medical device design, sustaining, manufacturing, or field/service engineering.
• Expertise: Strong expertise in analog, digital, and mixed-signal circuit analysis and debugging. Proven ability in system-level troubleshooting across hardware, firmware, and integrated systems. Hands-on experience with lab equipment (oscilloscopes, logic analyzers, multimeters, power analyzers). Experience with schematic review, PCB analysis, and implementing design changes (ECOs).
• Knowledge: Knowledge of DFM, DFR, and design for serviceability principles. Experience supporting manufacturing, yield issues, and production problem resolution. Ability to drive corrective and preventive actions for field and internal quality issues. Experience with component selection, qualification, obsolescence management, and supplier engagement. Strong understanding of cGMP, ISO 13485, and regulated medical device environments. Experience with CAPA, complaint investigations, audits, and design documentation. Knowledge of risk management (ISO 14971), FMEA, and hazard analysis. Demonstrated structured problem-solving skills (e.g., 5-Why, Fishbone, DOE) with end-to-end ownership.
• Leadership & Collaboration: Strong technical leadership and cross-functional collaboration skills, including influencing stakeholders. Excellent written and verbal communication skills for technical documentation and reporting.