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Senior Sustaining Engineer

Activ SurgicalBoston, Massachusetts, United States
Hybrid Full-time

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Experience Level

Mid to Senior

Qualifications

Qualifications and RequirementsBachelor's degree in Engineering or related field. Proven experience in sustaining engineering within medical device or similar industries. Strong understanding of manufacturing processes, quality assurance, and regulatory standards. Exceptional problem-solving skills and ability to work collaboratively in a team-oriented environment. Excellent communication skills, both verbal and written, with a focus on technical documentation.

About the job

Job Title: Senior Sustaining Engineer

Location: Boston, MA

Employment Type: Full-time (Hybrid)

About Activ Surgical

Activ Surgical is a pioneering medical device startup dedicated to revolutionizing surgical advanced visualization through innovative imaging, computer vision, and artificial intelligence technologies. Our platform seamlessly integrates state-of-the-art solutions to elevate laparoscopic and minimally invasive surgical procedures.

Position Overview

As a Senior Sustaining Engineer, you will take charge of the manufacturing processes, sustaining efforts, and continuous improvements for the Activ Surgical platform. Acting as the primary technical liaison with our contract manufacturer, you will facilitate cross-departmental collaboration across Quality, Regulatory, Operations, and R&D teams. This role blends hands-on engineering expertise with structured problem-solving and detailed documentation in a dynamic startup environment.

Your duties will encompass sustaining engineering, investigating hardware issues, implementing design-for-manufacture strategies, and managing the product development cycle for our existing platform. You will collaborate closely with Quality and Regulatory teams on handling complaints, non-conformance reports (NCRs), corrective and preventive actions (CAPAs), and field investigations, ensuring the device adheres to reliability, manufacturability, and compliance standards.

Key Responsibilities

Manufacturing Leadership & Technical Interface

  • Act as the primary technical contact for the contract manufacturer, assisting with daily production, troubleshooting, and ensuring build readiness.
  • Lead the resolution of manufacturing challenges, including assembly difficulties, test failures, yield enhancements, and line-down incidents.
  • Review, approve, and contribute to updates in manufacturing documentation, including work instructions, testing procedures, and assembly processes.
  • Drive the implementation of engineering change orders (ECOs) while ensuring compliant and controlled distribution at the contract manufacturer.
  • Support manufacturing preparedness for engineering builds, pilot runs, and ongoing production.

Sustaining Engineering & Quality Investigations

  • Lead root-cause analysis and corrective action initiatives for hardware-related issues, including complaints, NCRs, CAPAs, and field returns.
  • Collaborate with Quality and Regulatory teams to ensure investigations and enhancements comply with ISO 13485 and FDA Quality System Regulations (QSR).
  • Oversee sustaining engineering tasks to bolster reliability, robustness, and performance of the current hardware platform.
  • Maintain hardware documentation and facilitate updates to risk management, verification, and traceability as necessary.

Design for Manufacture & Process Enhancements

  • Champion design for manufacture (DFM), design for assembly (DFA), and process improvement initiatives aimed at increasing manufacturability, reducing costs, and optimizing assembly/testing workflows.

About Activ Surgical

Activ Surgical is an innovative medical device startup committed to enhancing surgical procedures through advanced imaging and AI technology, focusing on minimally invasive techniques.

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