Sr. Mechanical Engineer

Job Title: Sr. Mechanical Engineer (x2)
Location: Primarily Sumter, South Carolina (with travel to Chicago and Boston)
Duration: 12 Months

Position Overview

We 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.

Required 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.

Preferred Qualifications

• 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.