Bachelor's degree in Mechanical Engineering or Manufacturing Engineering, or equivalent.
Minimum of 4 years of experience in Medical Device Manufacturing Engineering.
Experience with Process Validations (IQ, OQ, PQ).
Demonstrated ability to develop manufacturing processes and technologies.
Knowledge of PFMEAs (Process Failure Mode and Effects Analysis).
Proficient in data analysis using Minitab.
Responsibilities
Evaluate process and design options for manufacturability.
Collaborate in teams and contribute individually in a dynamic environment.
Communicate effectively across various organizational levels.
Manage multiple tasks, prioritize efficiently, and meet deadlines.
Maintain strong organization and detail-oriented follow-up.
Ensure compliance with FDA regulations and internal policies.
Benefits
Opportunity to work in a fast-paced medical device manufacturing environment.
Collaboration with a skilled multidisciplinary team.
Potential for personal and professional growth within the company.
Full Job Description
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
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
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
