Sustaining Engineer

Bridge to Life LTD•Duluth, GA

About The Position

The Sustaining Engineer employs engineering expertise to sustain and optimize Bridge to Life’s medical device portfolio through maintenance and updating of technical documentation, management of component obsolescence, execution of minor design modifications, and support for production and contract manufacturing, as well as provision of technical data and testing to support regulatory submissions. All these initiatives strive to maintain the quality and regulatory compliance for Bridge to Life’s comprehensive suite of organ preservation solutions and perfusion technologies.

Requirements

Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, manufacturing engineering, electrical engineering, or equivalent, with a minimum of 2 years of relevant sustaining‑ or field‑support experience; or Master’s degree with at least 1 year of relevant experience.
Proficiency in design tools and software such as SolidWorks, AutoCAD, Inventor, or similar software.
Demonstrated experience updating and maintaining design control documentation (DHF, DMR, change‑control packages) and authoring technical reports.
Proven track record of leading V&V activities, including writing test protocols, conducting testing, and generating reports
Working knowledge of medical‑device regulations and standards, including FDA QSR (21 CFR 820), EU MDR, and ISO 13485.
Experience managing component obsolescence and vendor qualification to mitigate supply‑chain risk.
Skilled in root‑cause analysis and CAPA process for field issues.
Strong analytical and problem‑solving abilities, with the capacity to interpret field data and translate findings into proposed design solutions and engineering requirements.
Excellent technical writing and verbal communication skills, with proven ability to collaborate across cross‑functional teams and with external partners (Contract Manufacturers, regulatory bodies, notified bodies).
Experience operating within controlled cleanroom environments, including hands‑on familiarity with facility qualification (IQ/OQ/PQ) and commissioning processes for new or upgraded manufacturing facilities

Nice To Haves

Background in FDA regulated devices, preferably organ preservation or perfusion technologies, is highly desirable.

Responsibilities

Collect, analyze, and interpret post‑market performance, complaint, and field data to support sustaining engineering activities
Update and maintain Design History Files (DHF), change‑control records, and technical documentation to incorporate sustaining changes and obsolescence solutions.
Translate customer feedback and change requests into detailed design inputs and engineering requirements.
Coordinate and oversee verification and validation testing for design updates, ensuring alignment with regulatory standards.
Conduct targeted technical research and analysis, providing the engineering rationale and crafting detailed technical documents, reports, and change‑control packages to support regulatory submissions and responses across multiple markets (e.g., FDA, EU MDR, and other jurisdictions).
Collaborate with internal and external regulatory and manufacturing partners—including Contract Manufacturers and BTL sites—to drive and maintain product approvals (FDA clearances, CE marks, etc.).
Assist with third party contractor/project managers/vendor/service provider to develop turn-key manufacturing capabilities.
Assists in planning, equipment specification and procurement, IQ/OQ/PQ, Stability Studies, quality systems development and/implementation, regulatory (FDA) approvals and certifications.
Collaborates with operations managers to develop and implement controls and improvements.
Manage component obsolescence and vendor qualification to mitigate supply‑chain risk.
Lead or support root‑cause investigations and CAPA activities for field issues.
Provide on‑site engineering support and troubleshooting for manufacturing and assembly issues; coach operators on design intent and process controls.