Sr. Manufacturing Engineer - Equipment & Process Development

A hands-on and highly skilled engineer to support our engineering and manufacturing teams in building, troubleshooting, and improving production equipment. This individual will work closely with senior engineers on the development of custom equipment, support manufacturing line needs, and assist in the deployment of new processes and tooling to scale production.

This position requires a mechanically and electrically inclined individual who thrives in a fast-paced, regulated medical device environment and enjoys rolling up their sleeves to solve complex challenges.

This individual will collaborate closely with Software, QA, Regulatory, Product Development, Clinical Affairs, and external partners to execute a scalable validation strategy and drive efficiencies in testing and documentation for regulatory submissions.

• Support the design, fabrication, assembly, and modification of production and R&D equipment and production equipment.
• Troubleshoot and maintain mechanical and electromechanical systems on the manufacturing floor.
• Collaborate with engineers on new equipment builds and upgrades.
• Assist in documenting mechanical and electrical systems, including updating redlines and as-built drawings.
• Perform bench and hands-on testing of prototype systems and fixtures.
• Own the organization and upkeep of shared tools, equipment, and R&D lab space.
• Work with aluminum extrusion systems (e.g., 80/20) to fabricate test stands, equipment frames, and fixtures.
• Assemble and modify low-voltage control panels (24VDC, 120VAC), and perform electrical troubleshooting.
• Support documentation activities including pneumatic, electrical, and mechanical diagrams.

• Associate’s degree in a technical field or equivalent hands-on experience.
• Bachelor’s degree in Biomedical, Mechanical, Electrical, or Systems Engineering preferred.  Associate Degree acceptable with appropriate experience.
• Minimum 5 years of experience in medical device engineeringor FDA regulated industry preferred
• Proficient with hand and power tools (drill, grinder, circular saw, jig saw).
• Skilled in use and basic maintenance of machine tools such as:
  • Knee mill
  • Drill press
  • Band/chop saws
  • Engine lathe
• Experience with 3D printing (FDM and SLA), including troubleshooting and routine maintenance.
• Familiarity with GD&T, pneumatic/fluidic diagrams, and electrical schematics.
• Panel building and modification experience preferred.
• Ability to read and modify electrical drawings and control panel layouts.
• Strong organizational skills and attention to detail.
• Self-directed, proactive, and comfortable working in a team-oriented environment.