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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