Process Engineer Level I (Medtech)

TL;DR

Process Engineer Level I (Manufacturing/Medtech): Identifying and implementing changes to improve manufacturing processes, efficiencies, and quality standards for diagnostic instruments with an accent on Lean principles, process validation, and cost reduction. Focus on optimizing factory utilization through Value Stream Mapping, executing IQ/OQ/PQ validations, and reducing process variation using SPC and Root-Cause Analysis.

Location: Austin, Texas, USA (Onsite)

Company

hirify.global is a global leader in diagnostic solutions, developing innovative diagnostic assays and instruments to improve healthcare worldwide.

What you will do

• Lead process improvement initiatives to enhance manufacturing efficiency, reduce costs, and implement new tooling and equipment.
• Develop and maintain Manufacturing Instructions and routings, ensuring effective training for new or changed processes.
• Manage and execute process validation activities, specifically Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Apply Lean methodologies (DMAIC, Kaizen, PDCA) to optimize equipment layouts and work cell efficiency.
• Monitor and reduce process variation using Statistical Process Control (SPC), Root-Cause Analysis, and Tableau dashboards.
• Analyze manufacturing and field defect data to design and implement process improvement programs.

Requirements

• Bachelor's Degree in Industrial, Manufacturing, or Mechanical Engineering.
• 5+ years of process engineering or manufacturing experience (or 2+ years with an advanced degree).
• Experience in a GMP and FDA regulated industry or an ISO certified organization.
• High proficiency in Microsoft Word, Excel, Access, Visio, and PowerPoint.
• Strong statistical and data analysis skills, including knowledge of SPC and Design of Experiments (DOE).
• Must be authorized to work in the United States.

Nice to have

• Lean Six Sigma Black Belt certification.
• ASQ Certified Quality Engineer.
• Mechanical design capabilities utilizing Solidworks.

Culture & Benefits

• Competitive salary and benefits package.
• Opportunity to work in a global environment collaborating with international colleagues.
• Inclusive and supportive culture that values diversity and unique perspectives.
• Impactful work directly contributing to patient care and global healthcare solutions.