About Anodyne Surgical Anodyne Surgical is a privately held, mid-size manufacturing company specializing in producing disposable ophthalmic needles used primarily in cataract and LASIK eye surgeries. We are deeply committed to getting the job done right, no matter what it takes. If you're a problem-solver who's ready to jump in wherever needed, you'll thrive at Anodyne Surgical.

Position Overview Anodyne Surgical is looking for a Mechanical Engineer who is fully engaged on the production floor, capable of solving problems on the spot, and willing to take ownership of machinery, process improvements, and maintenance operations. This role will work side-by-side with the Production Manager as well as collaborating closely with Quality Assurance and Regulatory Affairs to ensure our products and processes meet the highest standards.

This position is ideal for someone who is mechanically skilled, can work autonomously, thrives in fast-paced environments, and isn't afraid to roll up their sleeves to keep production running smoothly.

Key Responsibilities

Troubleshoot, repair, and optimize production equipment to minimize downtime

Oversee and direct maintenance personnel; implement preventive maintenance programs

Collaborate with the Production Manager to identify and resolve operational challenges

Support process improvements, equipment upgrades, and new equipment installations

Interface with Quality and Regulatory teams to ensure equipment and processes meet FDA, ISO 13485, and internal standards

Create and maintain accurate documentation, including drawings, SOPs, maintenance logs, and change records

Assist in the development and validation of new manufacturing processes or modifications

Contribute to nonconformance investigations and root cause analysis

Ensure ongoing compliance with medical device manufacturing regulations and company policies

What We're Looking For:

Bachelor's degree in Mechanical Engineering or related field

3+ years of hands-on mechanical or manufacturing engineering experience, preferably in the medical device industry

Strong working knowledge of mechanical systems, machine troubleshooting, and process support

Proficiency with CAD software (SolidWorks )

Familiarity with FDA regulations, ISO 13485, and cGMP

Experience working cross-functionally with Quality, Regulatory, and Production teams

Proactive, resourceful, and ready to do what it takes to keep things moving

Comfortable taking initiative and driving improvements from the ground up

What We Offer:

Competitive compensation and benefits

401(k) retirement plan

11 paid holidays

PTO

Opportunities to take on leadership and grow your career

Please send your resume to jhercules@anodynesurgical.com to apply.