Katalyst Healthcares and Lifesciences
Katalyst Healthcares and Lifesciences

Process Engineer - Medical Device

Tonawanda, NY, US • Posted 60+ days ago • Updated 8 days ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Documentation
  • Regulatory Compliance
  • Process Improvement
  • Process Engineering
  • Medical Devices
  • Design Of Experiments
  • Statistics
  • Minitab
  • ISO 13485
  • GMP
  • Problem Solving
  • Conflict Resolution
  • Communication
  • Collaboration
  • Process Optimization
  • Continuous Improvement
  • Manufacturing
  • Lean Manufacturing
  • Six Sigma

Summary

Summary :

Key Responsibilities :
  • Design, develop, and optimize manufacturing processes for medical devices.
  • Execute Design of Experiments (DOE) to improve process performance.
  • Perform process characterization and statistical analysis (e.g., using MINITAB).
  • Collaborate with cross-functional teams including Engineering, Quality, and Operations.
  • Support process documentation for regulatory compliance (FDA, ISO 13485).
  • Identify process improvements and implement corrective actions.
  • Strong knowledge of process engineering principles in a medical device environment.
  • DOE and statistical analysis experience (MINITAB or similar tools).
  • Familiarity with process validation and qualification.
  • Understanding of regulatory standards: FDA, ISO 13485, GMP.
  • Excellent problem-solving, communication, and collaboration skills.

Education & Experience :
  • Previous experience in process optimization and continuous improvement in a regulated environment.
  • Experience with manufacturing equipment selection, setup, and troubleshooting.
  • Knowledge of lean manufacturing and Six Sigma methods.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 56933c776aa9ff3f968076bef9d3faf5
  • Posted 30+ days ago
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