Manufacturing Process Engineer

Katalyst CRO; Plano (TX); On-site; USD 85,000 - 110,000; Full time

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.

Skills

Process engineering

DFM principles

Communication skills

Multitasking

Attention to detail

Regulatory compliance

Education

Bachelor's in Mechanical Engineering

Bachelor's in Manufacturing Engineering

Tools

IQ/OQ/PQ

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