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:

• 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