Manufacturing Engineer-Medical Device

The Manufacturing Engineer Contractor will support the design, validation, implementation, and optimization of manufacturing processes and equipment for ophthalmic medical devices used in cataract and vitreoretinal surgeries. This role is hands‑on and highly technical, with a strong focus on equipment validation, statistical process control, and continuous improvement in a regulated medical device manufacturing environment. Key Responsibilities Lead, execute, document, and manage validation activities (IQ/OQ/PQ) to support the introduction or modification of automated and semi‑automated production equipment and processes. Design, develop, validate, and implement manufacturing processes for ophthalmic medical devices. Provide hands‑on engineering support for manufacturing equipment before, during, and after release to production. Apply Lean Manufacturing and Six Sigma methodologies to optimize production processes. Implement Continuous Monitoring using Statistical Process Control (SPC) to maintain equipment and processes in a validated state. Perform continuous statistical analysis of Critical Quality Attributes (CQAs) and process indicators to ensure compliance with product specifications (CpK / process capability). Design fixtures and create technical drawings using CAD software (e.g., SolidWorks) to support daily production operations. Develop and maintain standard work instructions and procedures to ensure robust and high‑quality manufacturing processes. Promote cross‑functional collaboration through clear communication and effective coordination with all departments. Required Skills & Competencies Medical Device Validation (IQ, OQ, PQ) Statistical Process Control (SPC) Statistical Analysis techniques including: DOE

ANOVA

Gage R&R T‑Test Tolerance Interval Analysis Control Charts Process Capability (CpK) Proficiency with statistical software (Minitab) CAD design experience (SolidWorks or equivalent) Strong technical writing skills Effective public speaking and communication skills Preferred Skills Manufacturing simulation software experience (FlexSim – preferred, not required) Education & Experience Required: Bachelor’s Degree in Engineering or Biomedical Engineering Minimum of 1+ year of professional experience in a Medical Device Manufacturing environment Preferred: Master’s Degree in Engineering or Biomedical Engineering

12‑MONTH CONTRACT

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