Manufacturing Process Engineer

Katalyst CRO; Plano (TX); On-site; USD 80,000 - 100,000; Full time

Job summary

Katalyst CRO is seeking a Manufacturing Process Engineer in Plano, Texas. The candidate will develop manufacturing processes for medical devices, ensure compliance with FDA regulations, and contribute to process validations. This role requires a Bachelor's degree in Mechanical or Manufacturing Engineering and at least 4 years of experience in medical device manufacturing. Strong communication and organizational skills are essential, as well as experience in process validation and data analysis using Minitab.

Qualifications

• Minimum experience of 4 years in Medical Devices - Manufacturing Engineering.
• Experience developing manufacturing processes and technologies.
• Experience working on PFMEAs.

Responsibilities

• Evaluate process and design alternatives based on Design for Manufacturability principles.
• Complies with FDA regulations and company policies.
• Multitasks and meets deadlines in a timely manner.

Skills

Process Validations (IQ, OQ, PQ)

Data analysis using Minitab

Design for Manufacturability principles

Team collaboration

Strong verbal and written communication

Education

Bachelor's in Mechanical Engineering or Manufacturing Engineering

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
• 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