Activ
Sustaining Engineer
Boston, Massachusetts, United States · Full-time
Sponsorship not specifiedDetected 128 days ago
Computer VisionSystems EngineeringMechanical DesignElectrical EngineeringFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem Solving
About the role
- 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.
- 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.
Responsibilities
- Manufacturing Leadership & Interface with Contract Manufacturer 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.
- Sustaining Engineering & Quality Investigations 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.
- Design for Manufacture & Process Improvements Lead DFM, DFA, and process-improvement initiatives to enhance manufacturability, reduce cost, and streamline assembly/test processes.
Requirements
- 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.
- 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.
- Qualifications Required BS in Mechanical Engineering, Electrical Engineering, Systems Engineering, or related field.
Nice to have
- Preferred Experience with electromechanical, imaging, optical, or robotic systems.
Benefits
- 6-10+ years of experience in hardware, sustaining engineering, or manufacturing engineering within medical devices or regulated electromechanical systems.
- Full-time (Hybrid) About the Company Activ Surgical is an early-stage medical device startup focused on transforming surgical advanced visualization through advanced imaging, computer vision, and AI.
This listing is sourced directly from Activ's careers page and normalized into a canonical job model.