Senior Process Development Engineer

Megan Patterson

Engineer
Burnsville, MN
Posted 4 weeks ago

Basic Function

The Senior Process Development Engineer will develop production processes that enable product scale-up and technology transfer from R&D into manufacturing.  This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Responsibilities

  • Development of existing and new manufacturing processes (manage, communicate, document, analyze, train)
  • Perform upstream processing and ensure scalability of operations during process development.
  • Interface cross-functionally with research and development, sales, marketing, supply chain, quality, and manufacturing teams to define technical requirements, develop processes, and prepare documentation.
  • Execution of Process Qualifications
  • Generation of Process Risk documentation
  • Identification, procurement, installation, and qualification of manufacturing equipment
  • Transfer of new processes and designs into the production environment
  • Identification of new technologies to improve efficiency, enhance quality, and reduce costs of existing and new products.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Investigation of the IP landscape for confirmation of freedom to operate with respect to the processes being developed.

Qualifications

  • Minimum of 5+ years’ experience working in medical device industry; disposable device experience desired, preferably with catheters and delivery sheaths.
  • Four year degree in relevant discipline
  • Experience with reflowing, bonding, braiding, injection molding, and various other processes required for the assembly and production of complex, disposable medical devices.
  • Knowledge of FDA, GMP, and ISO 13485; any experience with QSR implementation is desired, but not required.
  • Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
  • Strong attention to detail including analytical and problem-solving skills.
  • Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering.
  • Proficiency with Solidworks and designing fixturing and equipment
  • Deep knowledge in the application of statistical techniques to process development and improvement.
  • Previous start-up experience, a plus, but not required.
  • Proven track record of working with design engineers to reduce costs and improve a design for manufacturability

Working Conditions

  • Light work, exerting up to 20 lbs. of force or less.
  • Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
  • Requires fingering, repetitive motion, talking and hearing.
  • Significant work pace & pressure due to deadlines

To apply, please submit your resume and cover letter documents below.

Job Features

Job CategoryEngineering
Position reports to:Engineering Manager
Position Status:Exempt

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