Process Improvement Engineer I (MedTech)

Location: On-site in Bethlehem, Pennsylvania, United States. Travel may be required to local Bethlehem sites within a 10-mile radius, with limited additional travel for training, audits, or collaboration.

Salary: $62,000–$107,000 per year

Company

hirify.global develops diagnostic products, molecular sampling tools, and laboratory testing solutions for global health and wellness.

What you will do

• Support investigations and improvements of manufacturing processes to increase quality and efficiency while meeting regulatory requirements.
• Review process trending data and investigate out-of-control conditions and non-conformances.
• Implement corrective actions and establish monitoring requirements for Critical to Quality product and process attributes.
• Support scale-up, technology transfer, validation, engineering studies, and qualification of new or improved processes.
• Prepare and update manufacturing procedures and technical documentation.
• Ensure compliance with safety and regulatory policies while working with laboratory equipment and potentially hazardous substances.

Requirements

• Bachelor of Science degree in Engineering; Chemical Engineering preferred, or Mechanical or Manufacturing Engineering.
• 1–2 years of experience in process development or improvement for chemical- or biological-based products.
• Analytical and problem-solving skills, including experience with Statistical Process Control, Design of Experiments, and root cause analysis.
• Knowledge of Microsoft Office; familiarity with SharePoint, OneDrive, and Teams.
• Ability to communicate effectively and give and follow written and oral directions.
• Ability to perform precise manual tasks, use PPE, and occasionally lift or transport laboratory materials weighing up to 25 pounds.

Nice to have

• Experience with diagnostic assays, medical devices, pharmaceuticals, new product development, or technology transfer.
• Knowledge of Good Manufacturing Practices, process validation, and equipment qualification.
• Six Sigma certification, SolidWorks or equivalent 3D CAD experience, MS Project, SAP, or ERP experience.
• Experience leading process improvement or new product transfer projects.

Culture & Benefits

• Medical, dental, vision, disability, and life insurance benefits.
• 401(k) plan with company matching contributions.
• Paid time off, maternity leave, and parental leave coverage.
• Job-related training programs, employee assistance, referral, and service recognition programs.
• Free on-site parking and opportunities to participate in employee committees, events, clubs, and community initiatives.