Medical Device Process Engineer: Validation & Development

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

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.