Sustaining Engineer Level II

Elevaris Medical Devices • Wilmington, MA

4d

About The Position

The Sustaining Engineer supports released medical devices across their full product lifecycle to ensure ongoing safety, quality, and regulatory compliance. This role emphasizes product sustaining activities, including compliance assessments and remediation efforts. The Sustaining Engineer leads cross-functional collaboration with design, compliance, manufacturing, and post-market teams to support products currently on the market.

Requirements

• Bachelor’s degree in engineering (Mechanical, Biomedical, or related field)
• 3–6 years of engineering experience in a regulated industry, preferably medical device
• Working knowledge of FDA QSR, ISO 13485, EU MDR requirements and design controls
• Experience with CAD software (AutoCAD, SolidWorks) and other engineering and statistical tools
• Experience with structured problem-solving tools (e.g., 5 Whys, Fishbone, FMEA)

Nice To Haves

• Project planning skills and collaboration to plan, schedule, and perform tasks.
• Ability to work effectively in a fast-paced and constantly evolving environment
• Strong documentation, analytical, and communication skills

Responsibilities

• Develop and implement robust design procedures, processes and systems to ensure product sustainability and reliability that comply to US FDA and EU MDR requirements
• Investigate product compliance status, identify gaps, remediate gaps by conducting tests to evaluate compliance
• Lead the effort to bring existing designs and design history files to current meet current regulatory requirements
• Collect and analyze data to monitor product performance by evaluating the nonconformances, complaints, and field issues in compliance with FDA and ISO 13485 requirements
• Function as an independent contributor to plan, schedule, and perform tasks
• Perform root cause analysis and support Corrective and Preventive Actions (CAPA)
• Execute and document verification and validation activities per design control requirements
• Prepare and issue Engineering Change Orders (ECOs) for changes to released medical devices
• Collaborate with Quality, Regulatory, Manufacturing, Supply Chain, and Customer Support teams
• Ensure technical documentation is accurate, complete, and audit-ready
• Upholds and role-models company Values of Integrity, Invested, Inclusion and Ingenuity
• Other duties as assigned by management

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level