Manufacturing Process Engineer
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:
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.
- 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.
