Manufacturing Engineer

The Fountain Group is currently seeking a Manufacturing Engineer for a prominent client of ours. This position is located in Memphis, TN. Details for the position are as follows:

Job Description:

• Payrate: $38/hr W2
• Duration: 12 months (Possible extension based on performance & budget)
• 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.

Required skills:

• Bachelor of Science in Engineering is required
• Master of Science in Engineering is preferred.
• 2-4 years of manufacturing engineering experience in a regulated industry like medical device industry/Pharma industry/GMP manufacturing industry is required.
• Basic experience using AutoCAD or DraftSight to update and maintain existing floor plans and equipment layouts is required.
• Familiarity with validation activities (URS, FDS, IQ, OQ, PQ, VRA) is required.
• Knowledge of cleaning and passivation preferred

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 Smith & Nephew 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.

If you are interested in hearing more about the position, please respond to this posting with your resume attached.

Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.


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