Sr Process Engineer

Overview:

This role supports product development within the TB IDdx Automation team by ensuring appropriate manufacturing capability, process control, and supplier readiness. The position provides technical expertise related to production processes, materials, and validation activities throughout the product development lifecycle. This includes coordinating design transfer, managing external partners, and ensuring compliance with regulatory and quality standards.

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  Support new product development by defining and implementing appropriate manufacturing processes-either internally or through external suppliers.

  
  
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  Provide technical input on process design, production requirements, and validation strategies during early development phases.

  
  
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  Partner with suppliers to verify that proper process controls and quality mechanisms are in place to ensure reliable supply.

  
  
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  Ensure timely generation of design outputs to allow manufacturing teams to create documentation, establish processes, and complete validations in alignment with project schedules.

  
  
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  Ensure that Key Technical Challenges (KTCs) and Critical to Quality (CTQ) parameters are identified and addressed during development.

  
  
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  Collaborate with internal and external partners to develop budgetary estimates for cost of manufacture.

  
  
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  Work with Procurement to ensure suppliers are aligned with appropriate supply channels.

  
  
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  Lead design transfer activities and ensure that the Device Master Record (DMR) is compiled, accurate, and properly maintained.

  
  
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  Assist with process verification and validation activities, ensuring full compliance with validation plans, regulatory expectations, and GMP requirements.

  
  

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  Six Sigma certification and demonstrated practical application (preferred).

  
  
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  Proven experience leading and delivering complex, cross-functional projects.

  
  
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  Strong understanding of medical device requirements and experience working within a regulated QMS environment.

  
  
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  Experience with FDA-regulated products highly preferred.

  
  
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  Demonstrated ability to manage external suppliers and technical partners effectively.
  
  BS in Engineering or life sciences, Master's degree or higher preferred 6+ years of relevant technical experience in establishing and validating manufacturing processes