Senior Manufacturing Engineer

PUB362707

工作内容: Senior Manufacturing Engineer

Our client is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. Their portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care.

  • Manage projects which support the OEM Strategic Initiatives
  • Manage transfer activities for specific production cells
  • Establishes and defines technical scope and objectives for strategic initiative projects
  • Develops project plans, specifies the project goals, strategy and schedules, identifies areas of risk, contingency plans, cost/budget estimates and allocation of resources or capital
  • Identifies and schedules project deliverables, milestones, and required tasks
  • Quickly and clearly communicates issues, risks, and risk mitigation plans to management
  • Prepares project status reports to keep management, customers, and contingency plans that may be required
  • Provide technical guidance to engineers and technicians in multiple OEM facilities in support of the OEM strategy
  • Liaison between Product Development and Manufacturing during product transfers to ensure successful transition and design for manufacturability
  • Support Process FMEAs and production transfer documentation
  • Coordinate the design, procurement, build and troubleshooting of tooling, machinery and test equipment
  • Reduce cycle times and identify process improvements utilizing lean manufacturing principles and quality first mentality
  • Independently write and execute validations and/or assist technicians and other engineers in executing validation protocols (IQ/OQ/PQ)
  • For Senior level only – Mentor and coach less experienced engineers and technicians
  • Drive a safety driven culture

职位要求

  • Bachelor's degree in Engineering required with a focus in Plastics, Manufacturing, Biomedical or Mechanical Engineering preferred.
  • 2 - 5 years' experience in a medical device manufacturing or heavily regulated industry.
  • Previous product transfer experience a plus
  • Project management
  • Experience with plastics manufacturing processes is preferred. (Injection molding, extrusion, Thermal forming, Bonding, Ultrasonic Welding, etc.)
  • Engineering Drawing creation and interpretation (Solidworks, AutoCAD, GD&T)
  • Capital Equipment Specification, Development, and Support
  • Familiar with design control, FDA regulation and GMP practices
  • Statistical Techniques/Analysis using Minitab or similar tool
  • Experience with Lean Six Sigma preferred, belt certification a plus
  • Ability to prioritize and work independently
  • Good oral and written communication skills
  • Self-starter with strong proactive work ethic, well-organized and detail-oriented who can work independently
  • Proficiency in Microsoft Office required
  • Spanish speaking a plus

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PUB362707

Account manager

Kenneth McGreevy
Brunel USA - Boston
k.mcgreevy@brunel.net

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