A leading technology firm in Plano, Texas is seeking a Manufacturing Engineer with a minimum of 4 years of experience in Medical devices. The ideal candidate will have expertise in process validations, develop manufacturing processes, and ensure compliance with FDA regulations. If you thrive in a fast-paced environment and possess strong communication skills, we want to hear from you.
Qualifications
Minimum experience of 4 years in Medical devices - Manufacturing Engineering.
Ability to work within a team and as an individual contributor.
Complies with U.S. FDA regulations and Company policies.
Responsibilities
Evaluate process and design alternatives based on Design for Manufacturability principles.
Develop manufacturing processes and technologies.
Perform PFMEAs and Data analysis.
Skills
Process Validations (IQ, OQ, PQ)
Data analysis (Minitab)
Design for Manufacturability
Strong verbal and written communication
Organizational and follow-up skills
Job description
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, which includes process characterization
Experience working on PFMEAs
Experience performing Data analysis (Minitab)
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 communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.