Job Title: Senior Sustaining Engineer

Location: Boston, MA

Employment Type: 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. Our platform integrates cutting-edge technology to enhance laparoscopic and minimally invasive procedures.

Position Summary

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.

Key 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
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

Cross-Functional Collaboration

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

Requirements

Qualifications

Required

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

Preferred

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

Benefits

Fortune 500 health and wellness benefits.

Activ Surgical

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