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Manufacturing Process Engineer

Karwell Technologies

Plano, TX

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JOB DETAILS
SKILLS
Communication Skills, Corporate Policies, Data Analysis, Detail Oriented, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, Follow Through, Maintain Compliance, Manufacturing, Manufacturing Design, Manufacturing Engineering, Manufacturing Process Engineering, Manufacturing/Industrial Processes, Mechanical Engineering, Medical Equipment, Minitab, Multitasking, Operations Processes, Organizational Skills, Presentation/Verbal Skills, Process Development, Process Validation, Regulatory Compliance, Regulatory Requirements, Time Management, Writing Skills
LOCATION
Plano, TX
POSTED
30+ days ago
Job Summary:
Manufacturing Process Engineer with experience in medical device manufacturing, responsible for developing manufacturing processes, performing validations, and ensuring compliance with regulatory requirements in a fast-paced environment.
Roles & Responsibilities:
  • Evaluate process and design alternatives based on Design for Manufacturability principles.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes, and meets deadlines in a timely manner.
  • Strong organizational and follow-up skills, with attention to detail.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
Requirements:
  • Bachelor's in Mechanical Engineering or Manufacturing Engineering or equivalent.
  • Minimum experience of 4 years in Medical Devices - Manufacturing Engineering.
  • Good experience working on Process Validations (IQ, OQ, PQ).
  • Experience developing manufacturing processes and technologies, including process characterization.
  • Experience working on PFMEAs.
  • Experience performing data analysis using Minitab.

About the Company

K

Karwell Technologies

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