Senior Manufacturing Engineer

Job Description

Pay Range: $65hr - $70hr

• The Sr Manufacturing Engineer is responsible for supporting and improving manufacturing processes within a regulated medical device environment.
• This role focuses on process validation, new product transfer, continuous improvement, tooling development, and cross-functional collaboration.
• The ideal candidate will have strong analytical skills and experience working in ISO 13485 and FDA regulated environments.

• Bachelor’s degree in Engineering or a related field.
• Minimum 5+ years of experience in medical device manufacturing or a similar regulated industry.
• Experience with continuous process improvement and process validations.
• Experience working in ISO 13485 and FDA regulated environments.
• Strong analytical, creative, and critical thinking skills.
• Ability to work in a fast-paced, cross-functional environment.
• Ability to travel within the United States as required.

• Experience supporting new and existing manufacturing processes.
• Experience leading new product transfer from R&D to manufacturing.
• Experience drafting and executing product, equipment, and process validations including IQ/OQ/PQ.
• Experience managing prototype and pilot production builds.
• Experience performing root cause analysis and implementing corrective actions.
• Experience developing and reviewing manufacturing and engineering documentation.
• Experience working with tooling, fixtures, PLM systems, and QMS processes.

• Support new and existing manufacturing processes, product changes, enhancements, tooling, and fixtures.
• Support prototype and pilot production activities, facilities planning, and process development.
• Interface with cross-functional departments to resolve production issues.
• Conduct investigation and testing of product processes.
• Lead manufacturing efforts associated with new product transfers.
• Draft and execute validations for products, equipment, and processes.
• Manage prototype and pilot builds including operator training and coordination with production planning.
• Analyze data to improve and ensure robust and repeatable manufacturing processes.
• Collaborate with internal departments and external services to implement process modifications and resolve issues.
• Review and develop manufacturing and engineering documentation.
• Provide solutions to complex issues related to process, equipment, materials, supply chain, documentation, validation, and QMS processes.
• Perform root cause analysis and implement process improvements to increase manufacturing yield.
• Support design and development of tooling and fixtures for new and existing products.
• Identify and implement new technologies to improve manufacturing processes and equipment design.
• Establish and maintain monitoring systems for key manufacturing process metrics.
• Present analytical data clearly to support decision-making processes.

• Bachelor’s degree in Engineering or related field required;
  Master’s degree preferred.