Senior Process Engineer (Medtech)

TL;DR

Senior Process Engineer (Medtech): Providing technical and sustaining engineering support for 24/7 manufacturing areas, including pack and clean processes, with an accent on equipment qualification and process validation. Focus on optimizing manufacturing concepts, improving production yields, and ensuring strict compliance with quality system regulations.

Location: Onsite in Tempe, Arizona, USA

Salary: $103,200 - $154,800

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical technologies.

What you will do

• Provide technical and sustaining engineering support within cleanroom manufacturing environments.
• Perform equipment qualifications (IQ), process validations (OQ, PQ), and gage R&R studies (TMV).
• Implement equipment and process modifications to enhance production efficiencies and yields.
• Integrate equipment and material capabilities to meet specific process and technology target specifications.
• Collaborate with product design and development personnel to ensure design and process compatibility.
• Generate and maintain rigorous documentation in compliance with quality system regulations.

Requirements

• Bachelor’s Degree in Engineering, Science or Technical field with 4+ years of experience, Master's with 2+ years, or a PhD.
• Unrestricted U.S. work authorization is required at the time of hire.

Nice to have

• Experience in medical device, pharmaceutical, or other highly regulated industries.
• Certification in Lean Sigma (Green/Black Belt) or experience with DRM/DFSS.
• Proficiency in DOE, statistical analysis methods, and tools like Minitab or JMP.
• Experience with SPC principles, including process capability analysis and control charts.
• Ability to program and troubleshoot automated assembly equipment or metrology tools.

Culture & Benefits

• Comprehensive health, dental, and vision insurance, including HSA and Healthcare Flexible Spending Accounts.
• 401(k) plan with employer contribution and matching.
• Paid time off, paid holidays, and short-term disability leave.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and global well-being program (Simple Steps).