Process Development Engineer

Location: Tempe, AZ (Hybrid – Minimum 3 days on-site required)

Schedule: Monday – Friday, 8:00 AM – 5:00 PM

Pay Rate: $60.00 - $63.00/hr W2

Duration: 12-Month Contract

Position Overview

Our client's Advanced Operations team is expanding its new product development efforts and is seeking a Process Development Engineer to support a newly launched project in Tempe, AZ.

This role focuses on upfront process development and design, working hands-on to define, build, and implement manufacturing processes, technology, and procedures for new product introductions.

What You Will Do

• Process Design & Implementation: Support upfront process development activities, determining how manufacturing processes should be designed, optimized, and implemented.
• NPI Engineering Support: Provide engineering support for new product and process introductions, ensuring all activities comply with company NPD procedures, GMP, and safety standards.
• Equipment & Validation: Assist in the selection, design, and specification of equipment. Conduct qualifications, validations, and Measurement System Analysis (MSA) studies, including writing, executing, and reviewing validation documentation.
• Process Improvement & Quality: Conduct capability studies for in-process inspection and generate required documentation. Participate in PFMEA, control plan, SOP, and PPAP generation associated with product transfers and launches.
• Testing & Analysis: Analyze equipment operating data and perform experimental testing to troubleshoot and reduce time to market while maintaining regulatory and cost requirements.
• Cross-Functional Collaboration: Drive effective communication with project stakeholders, provide technical guidance and training to manufacturing team members, and participate in process review meetings.

What You Need (Qualifications)

Required:

• Bachelor’s degree in Engineering (Process, Industrial, Systems, Mechanical, or related engineering discipline).
• 2 to 6 years of relevant experience in process engineering, manufacturing engineering, or process development.
• Strong technical background in upfront process design, equipment design, or validation execution.

Preferred:

• Experience in Medical Device manufacturing or another highly regulated industry (FDA environment).
• Solid understanding of Design for Manufacturing (DFM), statistical tools, and verification/validation techniques.
• Hands-on experience with process development, PFMEA, SOP generation, and PPAP.
• Lean Six Sigma Green Belt certification or relevant methodology expertise.