Process Engineering Manager

Overview

The Process Engineering Manager will lead and scale process engineering activities supporting the development, manufacturing, and commercialization of regulated products. This role is ideal for a hands-on technical leader with experience operating in regulated manufacturing environments, who can balance day-to-day execution with longer-term process optimization and growth initiatives.

This position will work cross-functionally with Engineering, Manufacturing, Quality, and Operations teams to ensure robust, compliant, and scalable processes as the business continues to grow.

• Lead, mentor, and develop the process engineering function, providing both technical guidance and people leadership
• Own and improve manufacturing and assembly processes, with a focus on yield, quality, cost, and scalability
• Drive process validation activities (IQ/OQ/PQ) and ensure compliance with applicable regulatory standards
• Partner closely with Quality and Regulatory teams to support audits, CAPAs, change control, and documentation
• Support new product introductions (NPI) by transferring processes from development to manufacturing
• Identify and implement continuous improvement initiatives (Lean, Six Sigma, DOE, root cause analysis)
• Collaborate with suppliers and contract manufacturers to support production and quality objectives
• Contribute to technical decision-making around equipment, tooling, materials, and process design
• Ensure proper documentation, SOPs, and work instructions are maintained and audit-ready

• Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, Manufacturing, or related field)
• 7+ years of process engineering experience in a regulated environment, preferably:
  Medical Devices, Diagnostics, Biotech / Pharma, Aerospace or similar highly regulated industries
• Prior people leadership experience (formal manager or strong technical lead)

• GMP, ISO 13485, or comparable quality systems
• Process validation and change control
• Manufacturing documentation and compliance
• Proven ability to work cross-functionally in technical, fast-paced organizations

• Experience supporting regulated manufacturing scale-up
• Background working with both low-volume/high-mix and scaled production
• Lean, Six Sigma, or other continuous improvement training or certification