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Sustaining Mechanical Engineer

United States, Durham · Job Posted February 16, 2026
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Job Description

We are seeking an experienced Sustaining Mechanical Engineers to join a sustaining and quality engineering organization. Supporting ongoing product lifecycle activities and engineer teams on major development and system-level programs. The role is hands-on, execution-focused, and highly collaborative, with direct involvement in design changes, corrective actions, and manufacturing support activities.

Job Responsibility

  • Execute sustaining engineering activities across released medical device products
  • Support end-of-life (EOL) component management and redesigns
  • Address manufacturability, reliability, and quality-driven design changes
  • Manage small to medium design updates as they arise from sustaining backlog
  • Perform mechanical design and updates using SolidWorks
  • Generate and update engineering drawings and documentation
  • Conduct root cause analysis for field, manufacturing, or test issues
  • Support corrective actions and CAPA-related design changes
  • Develop and author test plans for design changes
  • Work closely with test technicians and lab personnel
  • Support execution, troubleshooting, and interpretation of test results
  • Ensure changes meet internal quality and validation expectations
  • Create and process engineering change orders within change management system (ARIS)
  • Work within ERP and documentation systems
  • Ensure traceability, documentation completeness, and compliance

Requirements

  • Bachelor’s degree in Mechanical Engineering or related discipline
  • 5–10 years of experience in mechanical design and sustaining engineering
  • Strong experience in medical devices, regulated products, or similar highly regulated environments
  • Proficiency in SolidWorks and standard engineering documentation practices
  • Experienced with: Sustaining engineering and product lifecycle support, Root cause analysis and corrective actions, Manufacturing support and design-for manufacturability

Nice to have

  • Prior experience supporting products post-release
  • Familiarity with quality systems, CAPA processes, and validation workflows
  • Experience working directly in lab or manufacturing environments
  • Exposure to change management systems (ARIS or equivalent)
  • Comfort working with ambiguous, fast-moving sustaining priorities

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