Manufacturing Process Engineer

Katalyst Healthcares & Life Sciences • Contract • Plano, TX, US • 2d 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

Education & Experience:

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

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