Sustaining Engineer

Activ•Boston, MA

3d•Hybrid

About The Position

As a senior sustaining engineer, you will own the manufacturing, sustaining, and continuous improvement of the Activ Surgical platform. You will serve as the primary technical interface with our contract manufacturer while driving cross-functional alignment across Quality, Regulatory, Operations, and R&D. This role combines hands-on engineering, structured problem-solving and documentation within a fast-paced startup environment. Your responsibilities will span sustaining engineering, hardware issue investigation, design-for-manufacture efforts, and product development cycle management to the existing platform. You will work closely with Quality and Regulatory on complaints, NCRs, CAPAs, and field investigations while ensuring the device meets reliability, manufacturability, and compliance expectations.

Requirements

BS in Mechanical Engineering, Electrical Engineering, Systems Engineering, or related field.
6–10+ years of experience in hardware, sustaining engineering, or manufacturing engineering within medical devices or regulated electromechanical systems.
Strong experience working directly with contract manufacturers and troubleshooting production issues.
Demonstrated expertise in root-cause analysis methods (e.g., fishbone, FMEA, 5-Whys).
Hands-on experience with DFM/DFA, ECO processes, and hardware change control.
Working knowledge of ISO 13485 and FDA QSR.
Strong communication and cross-functional collaboration skills.

Nice To Haves

Experience with electromechanical, imaging, optical, or robotic systems.
Familiarity with risk management (ISO 14971), verification/validation, and reliability testing.
Experience supporting scaling from prototype to pilot and manufacturing transfer.
Experience with globally distributed manufacturing partners.

Responsibilities

Serve as the primary technical point of contact for the contract manufacturer, supporting day-to-day production, troubleshooting, and build readiness.
Lead resolution of manufacturing issues including assembly challenges, test failures, yield improvements, and line-down events.
Review, approve, and support updates to manufacturing documentation including work instructions, test procedures, and assembly processes.
Drive implementation of engineering changes (ECOs) and ensure compliant and controlled rollout at the CM.
Support manufacturing readiness for engineering builds, pilot runs, and sustaining production.
Lead root-cause analysis and corrective action efforts for hardware issues, including complaints, NCRs, CAPAs, and field returns.
Collaborate with Quality and Regulatory to ensure investigations and improvements comply with ISO 13485 and FDA QSR.
Own sustaining engineering activities to improve reliability, robustness, and hardware performance of the current platform.
Maintain hardware documentation and support updates to risk management, verification, and traceability as needed.
Lead DFM, DFA, and process-improvement initiatives to enhance manufacturability, reduce cost, and streamline assembly/test processes.
Identify and execute opportunities for component optimization, improved assembly flow, and enhanced hardware repeatability.
Support development and improvement of test fixtures, equipment, and hardware inspection methods.
Provide hardware insights to the platform team on small enhancements and incremental design improvements.
Partner closely with Quality, Regulatory, Operations, and R&D to ensure hardware meets technical, compliance, and production requirements.
Support verification/validation activities and contribute to updates to design control documentation.
Coordinate with internal teams on issue resolution, hardware changes, and long-term improvement strategies.