Manufacturing Engineer

Pay range: 30-37/hr

• depending on experience Role Overview As a contract Engineer, you will contribute to cleaning and passivation systems under the supervision of a cleaning SME for orthopedic medical devices.

You will execute validation activities, support engineering testing, and drive project plans within a regulated manufacturing environment. In this role, you will develop technical depth in learning and validation while supporting larger projects and cross-functional initiatives. Responsibilities

• Help draft, review, execute, and document Cleaning Validation Protocols (IQ, OQ, PQ)
• Support the installation, startup, and verification of new cleaning equipment Use precision measuring tools to verify equipment layouts against blueprints and confirm fit within physical spaces and utility configurations
• Troubleshoot cleaning equipment to optimize cleaning programs and process parameters required for medical implants
• Investigate and resolve cleaning deviations or out-of-specification (OOS) results
• Conduct risk assessments to prevent cross-contamination between medical device products Execute cleaning trials and process studies to optimize parameters such as time, temperature, and detergent concentration prior to formal validation
• Perform fixture testing to ensure complex devices are properly held, cleaned, rinsed, and dried during automated cleaning cycles
• Perform root-cause analysis to investigate cleaning failures or process deviations Create, revise, and maintain Standard Operating Procedures (SOPs) and Work Instructions to reflect validated cleaning processes
• Directly train or support the training of production personnel on updated cleaning processes and procedures
• Work cross-functionally with Manufacturing Engineering, Quality, Validation, and Operations teams
• Perform other duties as assigned by the Project Manager or Senior Engineer. Education
• Bachelor of Science in Engineering required
• Master of Science in Engineering desired Experience
• 2-4 years of manufacturing engineering experience in a regulated industry; medical device preferred.
• Basic experience using AutoCAD or DraftSight to update and maintain existing floor plans and equipment layouts
• Familiarity with validation activities (URS, FDS, IQ, OQ, PQ, VRA) is required.
• Knowledge of cleaning and passivation preferred Physical Demands Standing and walking in production areas for extended periods.

Lifting objects up to 40 lbs. occasionally. Use of personal protective equipment (PPE) as required.