The Senior Sustaining Engineer supports electromechanical medical devices by resolving field, service, supplier, and manufacturing issues that affect product quality, reliability, or continuity of operations. The role leads technical investigations using structured troubleshooting, root cause analysis, engineering testing, and data analysis to identify failure modes, verify contributing causes, and recommend corrective/preventive actions or other improvements. This position works closely with R&D, Manufacturing Engineering, and Quality to resolve issues and drive continuous improvement.
Key Responsibilities:
1. Lead technical investigations for manufacturing, servicing, and field issues to identify failure modes, contributing causes, corrective action opportunities, and risk considerations.
2. Troubleshoot electromechanical systems, assemblies, fixtures, equipment, and returned devices using structured engineering methods and hands-on diagnostic testing.
3. Apply structured root cause analysis, engineering characterization, DOE, statistical analysis, verification testing, and data trending to evaluate product and process performance issues.
4. Develop and execute electrical, mechanical, dimensional, and process-based test methods to characterize failures, verify root causes, and support technical decisions.
5. Author technical content for quality-system and operational investigations through documented analysis, test evidence, conclusions, and engineering recommendations.
6. Support sustaining activities, including design transfer, manufacturing readiness, process verification, equipment qualification, supplier changes, testing improvements, process changes, and design changes.
7. Communicate technical findings, risks, tradeoffs, and recommendations to cross-functional stakeholders to support investigation closure, corrective actions, and sustaining decisions.
8. Manage multiple sustaining priorities with basic project management discipline and conduct work in compliance with applicable procedures, policies, and internal controls.

9. Holds oneself and others accountable to conduct business in a manner compliant with Bioventus' Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.
10. Other duties as assigned.

Education and Experience (Knowledge, Skills & Abilities)
• 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.
• Lean, Six Sigma, continuous improvement, or design-for-manufacturing experience is considered a plus.

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