Senior Mechanical Manufacturing Engineer

Position Summary:

We are seeking a Senior Mechanical Manufacturing Engineer to support the sustaining, manufacturing, and continuous improvement of advanced medical device platforms featuring laser, optical, ultrasound, and RF technologies. This role focuses on resolving production issues, improving manufacturability and reliability, and managing component lifecycle and cost-down initiatives.

Duties & Responsibilities:

• Rapidly respond to production issues, identify root causes, and implement corrective and preventive actions.
• Lead engineering change orders (ECOs) to improve manufacturability, reduce cost, resolve obsolescence, and enhance reliability.
• Review production data and field performance to identify failure modes and drive design improvements.
• Support supplier troubleshooting and qualification activities; execute verification testing on replacement components.
• Develop and improve manufacturing test methods, assembly fixtures, and tooling to increase quality and throughput.
• Provide training and support to manufacturing personnel during build activities and engineering change implementation.
• Use CAD and FEA tools to update and validate mechanical and opto-mechanical assemblies and thermal systems.
• Maintain documentation for engineering changes, deviations, work instructions, and test protocols.
• Other duties as needed or required.

Minimum Requirements & Qualifications:

• B.S. in Mechanical Engineering with 3-5+ years experience in capital equipment, laser systems, or medical devices.
• Hands-on production support and sustaining engineering experience.
• Solid CAD skills (SolidWorks preferred); strong understanding of GD&T and tolerance analysis.
• Familiarity with plastic injection molding, sheet metal fabrication, and precision machining.
• Ability to analyze data and correlate simulation with empirical results (Excel, MATLAB, or equivalent).
• Effective communication and cross-functional collaboration skills.

Preferred Qualifications:

• Experience with opto-mechanical assemblies and thermal management systems.
• Familiarity with mechanical/thermal FEA tools, fixture design, and automated test equipment.
• Exposure to FDA Quality Systems, IEC 60601, and ISO14971.