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Job Description
Overview The Manufacturing Engineer will play a key role in developing, sustaining, and optimizing manufacturing processes for ophthalmic surgical medical devices. This role focuses on ensuring reliable, efficient, and compliant production through process engineering, equipment validation, continuous improvement, and cross‑functional collaboration in an FDA‑regulated and
ISO 13485
environment. Responsibilities Create and maintain manufacturing documentation including work instructions, BOMs, PFMEAs, process flow diagrams, and control plans. Lead equipment and process qualification activities (IQ/OQ/PQ). Support scalability of new products from R&D prototypes to full manufacturing. Partner with suppliers and internal teams to ensure equipment readiness and process capability. Conduct root‑cause analysis, lead CAPA activities, and support nonconformance investigations. Implement Lean, Six Sigma, SPC, and other continuous‑improvement methodologies. Develop tooling, fixtures, and jigs to improve manufacturability and operator safety. Monitor production metrics, yields, and process capability to drive improvements. Ensure compliance with
FDA 21 CFR 820, ISO
13485, and company quality procedures. Requirements Develop, optimize, and validate manufacturing processes for ophthalmic surgical instruments and devices. Create and maintain manufacturing documentation including work instructions, BOMs, PFMEAs, process flow diagrams, and control plans. Lead equipment and process qualification activities (IQ/OQ/PQ). Support scalability of new products from R&D prototypes to full manufacturing. Partner with suppliers and internal teams to ensure equipment readiness and process capability. Conduct root‑cause analysis, lead CAPA activities, and support nonconformance investigations. Implement Lean, Six Sigma, SPC, and other continuous‑improvement methodologies. Develop tooling, fixtures, and jigs to improve manufacturability and operator safety. Monitor production metrics, yields, and process capability to drive improvements. Ensure compliance with
FDA 21 CFR 820, ISO
13485, and company quality procedures. Qualifications Bachelor's degree in Mechanical, Manufacturing, Biomedical Engineering, or related discipline. 2+ years of manufacturing engineering experience in medical devices or precision manufacturing. Experience with process validation, statistical analysis, and manufacturing documentation. Solid understanding of medical device quality systems and regulatory requirements. Proficiency in CAD software and familiarity with DFM/DFA principles. Strong analytical, communication, and problem‑solving skills. Preferred Skills Experience with ophthalmic surgical device manufacturing, micro‑assembly, or optical components. Familiarity with cleanroom environments (ISO Class 7/8). Experience with automation, robotics, or high‑precision assembly tools. Knowledge of sterilization processes (EtO). Strong mechanical aptitude combined with excellent communication skills to collaborate across teams effectively. Join us to be part of a forward-thinking team dedicated to pushing the boundaries of manufacturing innovation! We value energetic professionals who thrive on solving complex challenges through creativity and technical expertise—empowering us all to produce world-class products efficiently and reliably.
