Medical Device Process Engineer: Validation & PFMEA

Katalyst CRO

Plano (TX)

On-site

USD 85,000 - 110,000

Full time

2 days ago

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Job summary

Katalyst CRO is seeking a Manufacturing Process Engineer in Plano, TX, with experience in medical device manufacturing. The role focuses on developing manufacturing processes, performing validations, and ensuring regulatory compliance in a fast-paced setting.

Required are a Mechanical or Manufacturing Engineering degree and at least 4 years in Medical Devices manufacturing, including IQ/OQ/PQ validations and PFMEA. Strong communication and analytical skills are essential.

Qualifications

Bachelor's in Mechanical Engineering or Manufacturing Engineering.
4+ years in Medical Devices - Manufacturing Engineering.
Experience with Process Validation IQ/OQ/PQ.
Experience with PFMEA and data analysis using Minitab.

Responsibilities

Evaluate process and design alternatives based on Design for Manufacturability principles.
Collaborate in a fast-paced environment as a team or individual contributor.
Communicate effectively at multiple levels within the organization.
Multitask, prioritize, and meet deadlines in a timely manner.
Maintain strong organizational and follow-up skills with attention to detail.
Ensure compliance with FDA regulations and other requirements.