Manufacturing Process Engineer
Katalyst Healthcares and Life Sciences
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.
- Evaluate process and design alternatives based on Design for Manufacturability principles
- bility 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
- 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
Vacancy posted 18 hours ago
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