Manufacturing Engineer

TeleflexJaffrey, NH
1d

About The Position

The Manufacturing Engineer is responsible for the design, development, and improvement of manufacturing processes and equipment in a medical device manufacturing environment. This is a hands-on position which will provide key technical support to the Jaffrey site. This person will have a leadership role in engineering functions such as specifying and validating new equipment and materials, troubleshooting processes, managing projects, and identifying and implementing process/product improvements. The engineer will work within a cross-functional value stream team to monitor and improve yields, resolve material issues, customer complaints and to review potential new business.

Requirements

  • Bachelor’s degree in engineering requiredo
  • Bachelor’s in Plastics, Chemical, Biomedical, or Mechanical preferred
  • 3+ years of experience of process development/improvement and manufacturing in a regulated manufacturing environment (ISO, FDA, etc.).
  • Experience in Medical Device environment preferred
  • Basic understanding of extrusion tooling and processes
  • Good working knowledge of manufacturing methods, and an ability to effectively persuade people of all different levels within the organization
  • Knowledge of precision extrusion, machining methods, tooling, and molding experience writing and performing qualifications of equipment, product, and processes
  • Experience with lean six-sigma manufacturing and preferably, green-belt certified
  • Proficient in Solidworks and/or comparable CAD software
  • Excellent oral and written communication skills
  • Ability to prioritize and work independently
  • Product transfer experience preferred.
  • Familiar with design controls, FDA regulation, and GMP practices
  • Rely heavily on experience and judgment to plan and accomplish goals

Responsibilities

  • Identify opportunities and implement changes to reduce variation and improve scrap rates and productivity
  • Develops manufacturing processes by designing and modifying equipment for fabricating, building, assembling, and installing components
  • Provide support to R&D, manufacturing, marketing, customer service, and interface with customers and suppliers
  • Using six sigma principles, identify key process parameters and develop monitoring tools to enable cost reduction efforts
  • Manage projects in a matrix organization as a team leader, whose duty encompasses the full scope of the project
  • Conduct validations independently and assist technicians and engineers in executing validation protocols (IQ/OQ/PQ/TMV)
  • Drive capability improvements in manufacturing areas
  • Mentor and coach less experienced engineers and technicians in developing new products and technologies
  • Assist and support OEM Strategic Initiatives (product line transfers)
  • Assist with the design of gauges, fixtures, tooling and methods
  • Conduct design and process FEMA’s
  • Implement cost reduction or cost avoidance by working closely with the Value Stream Team
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