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Senior Process Development Engineer
Danvers, MA

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Direct Hire

$100,000 - $125,000 / yr


Senior Process Development Engineeer – Extrusion Processes
 
Our client, a World Leader in Medical Device Manufacturing, has new openings for Process Development Engineers working in their world-renowned Center of Excellence in Danvers, MA.  In this exciting role as a Senior Process Development Engineer, you will have responsibility for developing catheter extrusion and other related processes for medical devices.  This role reports to the Product Development Manager and oversees and directs the work of a team of engineers and technicians working on next generation heart valve delivery catheter systems.  This role will also help develop new extrusion technologies
 
This is a Flexible position, people with lower/higher experience level are welcome to apply to this position (we have level II, Senior and Principal openings)
 
Senior Process Development Engineer Extrusion Responsibilities:
 
  • Proven track record of hands-on extrusion expertise in developing new extrusion process from ground up
  • Provides technical and sustaining engineering support in a manufacturing area.
  • Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. 
  • Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
  • Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
  • Interacts with product design and development personnel to ensure that processes and designs are compatible.
  • May develop and conduct statistical analysis or recommend additions to document work.
  • Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.
    • This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.
  • Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
  • Ensures processes and procedures are in compliance with regulations.
  • Generate and conduct validations independently and assist technicians and engineers in executing validation protocols (IQ/PD/PC/OQ/PQ/TMV)
  • Design tooling to support new extruded products or process improvements
  • Lead and support a team of Engineers and Technicians
  • Initiate, direct, and support projects to implement innovative equipment processes, and methods that enhance efficiency, improve safety, and increase profitability
  • Hands-on role which requiring on-site support and managing other employees
  • Proven ability to take the lead role in extrusion engineering functions which includes validating and troubleshooting processes, identifying and implementing process improvements, managing projects, and expanding extrusion capabilities
 
Senior Process Development Engineer – Extrusion Minimum Requirements
 
  • Bachelors degree required
  • Minimum of 4 years of relevant experience, or advanced degree with 2 years of experience with extrusion process
 
Senior Process Development Engineer – Extrusion Preferred Skills:
 
  • Hands-on-experience in extrusion process development with 8+ years of experience
  • Develop/mentor extrusion engineering talent pipeline with hands on experience.
  • Proven track record of extrusion expertise in developing any one or more of the following process from ground up is preferred: Multi-lumen extrusion, Free form extrusion, Vacuum forming extrusion, Shrink tubing, Intermittent / full A/B extrusion, Braided catheter extrusion, Extruded Coating, Multilayer co-extrusion, Bump tubing
  • Familiar with processing Pebax, Nylon derivates, polyurethane, engineering polymers
  • 5+ years of experience in an extrusion manufacturing environment, preferably in a medical device setting
  • Experience in process validations, statistics and SPC using Minitab software
  • Extensive knowledge of plastic chemistry and properties
  • Experience in transferring product from pilot to production
  • Proficient in designing, acquiring, and implementing new equipment and processes
  • Familiar with design controls, FDA regulation – ISO 13485, 21 CFR 820, and CGMP practices
  • Relies heavily on experience and judgment to plan and accomplish goals
  • Good working knowledge of GDT
  • Generate and conduct validations independently and assist technicians and engineers in executing validation protocols (IQ/PD/PC/OQ/PQ/TMV)
  • Design tooling to support new extruded products or process improvements
  • Lead and support a team of Engineers and Technicians
  • Initiate, direct, and support projects to implement innovative equipment processes, and methods that enhance efficiency, improve safety, and increase profitability
  • Hands-on role which requiring on-site support and managing other employees
  • Proven ability to take the lead role in extrusion engineering functions which includes validating and troubleshooting processes, identifying and implementing process improvements, managing projects, and expanding extrusion capabilities


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