Manufacturing Engineer I

What You'll Do:

Support the development, scale-up, validation, and continuous improvement of ophthalmic manufacturing processes. This role solves manufacturing challenges, develops engineering solutions and technical documentation, creates 3D CAD models and 2D drawings for assembly tools and fixtures, and partners with cross-functional teams to deliver high-quality, cost-effective products while ensuring compliance with FDA, ISO 13485, and Glaukos quality standards.

How You'll Get There:

• Develop, implement, and improve manufacturing processes, methods, tooling, and equipment to support production efficiency, quality, and cost objectives.
• Support new product introductions and sustaining engineering activities by providing manufacturing input during design reviews and ensuring manufacturability, scalability, and optimized yields.
• Troubleshoot product and process issues on the manufacturing floor, identify improvement opportunities, and implement corrective actions to enhance performance and reduce costs.
• Execute engineering documentation and validation activities, including protocols, reports, work instructions, risk assessments (FMECA), equipment qualifications, and process validations.
• Design and support fixtures, tooling, and manufacturing equipment using CAD while collaborating with suppliers and cross-functional teams to ensure operational readiness.

Required Qualifications:

• Bachelor's degree in Mechanical Engineering or related engineering discipline preferred.
• Engineering experience in a manufacturing environment
• Experience with new product development from concept through production release.
• Strong problem-solving and analytical skills.
• Experience with process development, equipment qualification, or validation.
• Collaborative team player with cross-functional experience.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• CAD experience preferred.
• Knowledge of cGMP, FDA regulations, and ISO 13485 preferred.
• Medical device and/or ophthalmic industry experience preferred.
• Ability to work in a cleanroom and under a microscope.
• ERP system experience preferred.

This position is based in Burlington, MA

#GKOSUS