Job Description

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.

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 preferred)
• 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.

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