Manufacturing Process Engineer

Katalyst Healthcares & Life Sciences

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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

Location

Plano, TX