Sr Sustaining Engineer

Key Responsibilities

• Lead technical investigations for manufacturing, servicing, and field issues to identify failure modes, contributing causes, corrective action opportunities, and risk considerations.
• Troubleshoot electromechanical systems, assemblies, fixtures, equipment, and returned devices using structured engineering methods and hands-on diagnostic testing.
• Apply structured root cause analysis, engineering characterization, DOE, statistical analysis, verification testing, and data trending to evaluate product and process performance issues.
• Develop and execute electrical, mechanical, dimensional, and process-based test methods to characterize failures, verify root causes, and support technical decisions.
• Author technical content for quality-system and operational investigations through documented analysis, test evidence, conclusions, and engineering recommendations.
• Support sustaining activities, including design transfer, manufacturing readiness, process verification, equipment qualification, supplier changes, testing improvements, process changes, and design changes.
• Communicate technical findings, risks, tradeoffs, and recommendations to cross-functional stakeholders to support investigation closure, corrective actions, and sustaining decisions.
• Manage multiple sustaining priorities with basic project management discipline and conduct work in compliance with applicable procedures, policies, and internal controls.

Education And Experience

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, Systems Engineering, Manufacturing Engineering, or a related engineering discipline.
• 7+ years of experience in design, test, sustaining, quality, or related engineering roles directly supporting electromechanical medical devices.
• Demonstrated experience troubleshooting complex issues within electrical, mechanical, manufacturing, or embedded systems.
• Hands-on experience with root cause analysis, engineering testing, design of experiments, statistical analysis, and data-driven technical decision-making.
• Proficiency using electrical and electromechanical diagnostic equipment, including HIPOT testers, oscilloscopes, function generators, power supplies, multimeters, and thermal measurement equipment.
• Experience working within medical device quality systems, manufacturing controls, complaint handling, CAPA, nonconformance, or product development environments.
• Ability to translate engineering data into practical technical conclusions, risk considerations, and corrective/preventive actions.
• Understanding of regulations and guidelines governing medical devices including knowledge of ISO 13485 and 21 CFR 820.
• Strong written and verbal communication skills with the ability to work cross-functionally and influence without direct authority.
• Ability to manage multiple priorities, work well within a team, and interact effectively with different levels and functions within the organization.
• Self-driven, curious, persistent, and able to exercise sound engineering judgment in ambiguous situations.
• Experience with IEC 60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, IEC 62133, or related standards for electromechanical product safety is highly preferred.
• Leverage Lean, Six Sigma, continuous improvement, or design-for-manufacturing experience is considered a plus.