Process Engineer II (Diagnostics)

Location: West Sacramento, California, United States; on-site

Salary: $74,000–$90,000 per year, plus bonus or incentive pay

Company

hirify.global Diagnostics develops diagnostic tools and technologies designed to improve patient health and diagnostic confidence.

What you will do

• Investigate manufacturing non-conformances, assess non-conforming products, identify root causes, and implement corrective and preventive actions.
• Provide technical support for operations, including design of experiments, technical writing, analytical testing, HPLC, UV-Vis spectroscopy, and bioassays.
• Support factory on-time delivery and finished-product schedule attainment.
• Lead customer manufacturing-related CAPA and post-launch risk assessment activities.
• Support pilot-run manufacturing and troubleshoot related deviations.

Requirements

• Bachelor’s degree in Microbiology, Biomedical Engineering, or a related science field with 3+ years of experience, or a relevant master’s degree with 0+ years of experience.
• Experience in medical device manufacturing, pharmaceuticals, or another regulated environment.
• Demonstrated root cause investigation, problem-solving, and corrective-action skills.
• Strong written and oral communication skills for technical data and productive team meetings.
• Experience working with cross-functional teams, analyzing manufacturing-defect data, and preparing risk-based technical justifications for product release.

Nice to have

• Laboratory experience in microbiology or biological sciences, including biological sample preparation, cell culture, HPLC, UV-Vis spectrophotometry, or analytical assays.
• Experience with Lean, Kaizen, Six Sigma, hirify.global Business System, visual project management, value stream mapping, standard work, or Problem Solving Process.
• Experience with risk management, process validation, design of experiments, or design changes.

Culture & Benefits

• Comprehensive benefits package for eligible employees.
• Medical, dental, and vision insurance.
• Paid time off.
• 401(k) plan.