Sr. Mechanical Engineer
Listed on 2026-07-01
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Engineering
Manufacturing Engineer, Mechanical Engineer, Quality Engineering, Automation & Mechatronics Engineer
Sr. Mechanical Engineer (x2)
Primarily Sumter, South Carolina (with travel to Chicago and Boston) Duration: 12 Months
Position OverviewWe are seeking two experienced Sr. Mechanical Engineers to support the restart of a previously mothballed medical device production line. This is a hands-on role that involves commissioning, testing, troubleshooting, and optimizing automated systems to achieve high Overall Equipment Effectiveness (OEE). Candidates must have a strong background in medical device automation and factory acceptance testing in a regulated environment.
Key Responsibilities- Execute Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for mechanical and automated systems.
- Troubleshoot and debug mechanical, electrical, and software issues related to high-speed automation.
- Ensure systems meet safety and ergonomic compliance standards.
- Optimize workflows and equipment performance for improved Overall Equipment Effectiveness (OEE).
- Perform precise measurements using optical/vision tools, particularly Cognex and Data Logic systems.
- Document test results, generate performance reports, and ensure traceability and compliance with regulatory standards.
- Work collaboratively with multidisciplinary teams including technicians and site engineers.
Skills & Qualifications
7-10 years of experience in mechanical engineering with a focus on line commissioning and automation in the medical device industry.
Proven experience in executing FAT/SAT protocols and debugging complex mechanical systems.
Expertise in improving workflow efficiency and optimizing OEE.
Strong troubleshooting, analytical, and problem-solving abilities.
Familiarity with ISO standards and regulated manufacturing environments.
Proficiency in MS Word, Excel, and Project.
Excellent verbal and written communication skills.
Experience with molding processes in medical device manufacturing.
Prior experience integrating with client-side engineering and operational teams.
Positive, team-oriented attitude and ability to work independently under minimal supervision.
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