Senior Manufacturing Engineer

Provide Manufacturing Engineering support to Operations through line support, continuous improvement, capacity improvements and new product transfers. Improve the overall efficiency of the manufacturing operation while optimizing human work factors, quality control, material flow, etc. by identifying areas for improvement through use of statistics and root cause analysis tools.

Line Support

• Provide general oversight and monitoring of machinery - including project coordination for maintenance, upgrades, and repair when needed
• Help with troubleshooting of problems within the manufacturing process
• Identify and implement GMP (good manufacturing practices) that apply to specific production area(s).
• Provide training as needed to ensure that the production team understands and follows GMP.
• Lead/own CAPA (corrective and preventative actions) to resolve production and customer issues.
• Lead formal failure analysis and issue resolution activities to ensure preventative action is accomplished.
• Provide work direction to Product or Process technicians as required.
• Create written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.g. qualifications, risk assessments, and work instructions).
• Provide hands-on manufacturing equipment and process trouble shooting.
• Provide operations department with effective technical support to meet manufacturing quality and quantity objectives.

Continuous Improvement

• Utilize project management skills to drive continuous improvement initiatives to optimize yield, quality, cycle time and/or ergonomics.
• Own and execute cost down initiatives on manufacturing lines.
• Initiate and lead lean transformations on manufacturing lines as well as within supporting areas.
• Identify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes, including troubleshooting of manufacturing issues when they occur.
  
  

Capacity Improvement

• Assess and monitor manufacturing capacity capabilities and reconcile with demand. Propose capacity improvement recommendations accordingly.
• Specify tooling, fixtures and equipment required to meet manufacturing capacity requirements.
• Coordinate efforts associated with planning, procuring, installing and qualifying tooling, fixtures and equipment.
  
  

New Product Transfers

• Work with product development engineering to drive back lessons learned as new products are being developed.
• Evaluate and provide input to product development teams to help ensure the introduction of a capable and efficient operation.
• Create/evaluate and release process documentation for new processes.
• Specify tooling, fixtures and equipment required to meet manufacturing capacity requirements.
• Coordinate efforts associated with planning, procuring, installing and qualifying tooling, fixtures and equipment.
• Train operations personnel on new processes.
  
  

• Minimum of 5 years of Manufacturing Engineering experience, preferably within the medical device manufacturing industry.
• CAD experience is a plus, preferably SolidWorks
• Familiarity with ISO 13485, FDA Design Control, CAPA, SCAR, and audit procedures.
• Experience in structured problem solving and use of statistical tools.
• Training and experience in Lean and Six Sigma, or equivalent.
• Experience in Design for Manufacturing, DFMEA, PFMEA, DOE, and Validations

• Prefer BS in Mechanical Engineering or Manufacturing Engineering.
• Prefer experience within the medical device manufacturing industry.
• Prefer SolidWorks

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