Process Development Engineer

The Process Development Engineer supports Kuros’ process development engineering activities for the Alpharetta manufacturing facility and broader US Operations objectives. This individual contributor role is responsible for developing, improving, validating, transferring, and sustaining manufacturing processes for Kuros’ product portfolio. The engineer will work closely with Operations, Quality, R&D, Supply Chain, Maintenance, and global counterparts to ensure manufacturing processes are safe, scalable, compliant, efficient, and capable of consistently meeting quality, cost, capacity, and customer demand expectations within an ISO 13485 and GMP-regulated environment.

This is a full-time, on-site position based out of Alpharetta, GA.

• Support process development engineering activities for Kuros’ US manufacturing operations, ensuring alignment with production demand, quality objectives, project priorities, and long-term capacity plans.
• Execute process design, optimization, scale-up, transfer, validation, and lifecycle management activities for new and existing manufacturing processes, including support for product introductions and process transfers from R&D or global manufacturing sites.
• Develop and support validation and qualification activities for manufacturing equipment, utilities, fixtures, test methods, and processes using appropriate IQ/OQ/PQ, process validation, and risk-based approaches.
• Create, revise, and maintain manufacturing documentation, including process flow diagrams, BOMs, routings, PFMEAs, control plans, work instructions, SOPs, batch records, validation protocols, validation reports, and engineering change documentation.
• Partner with Quality to ensure processes, documentation, validation packages, deviations, CAPAs, nonconforming material dispositions, and engineering changes comply with Kuros’ quality management system, ISO 13485, GMP, FDA expectations, and applicable regulatory requirements.
• Perform root cause investigations, failure analysis, and technical problem solving for manufacturing issues, discrepant components, process nonconformances, field feedback, and product performance concerns.
• Identify and execute continuous improvement initiatives to improve first pass yield, cycle time, throughput, capacity, product reliability, process capability, labor efficiency, safety, and cost using Lean Six Sigma methods such as DMAIC, DMADV, PFMEA, MSA, Gage R&R, Cpk analysis, line balancing, theory of constraints, and waste elimination.
• Support the design, selection, implementation, commissioning, qualification, and validation of manufacturing equipment, tooling, fixtures, inspection methods, and technology upgrades.
• Provide technical support for production readiness, process capability, training readiness, standard work, troubleshooting, and day-to-day engineering activities to ensure sustained manufacturing performance.
• Collaborate cross-functionally with Operations, Quality, R&D, Supply Chain, Maintenance, EH&S, and global Kuros teams to support manufacturing launch, ongoing production, process standardization, and continuous improvement.
• Collect, analyze, and communicate engineering data and KPIs related to quality, delivery, productivity, validation execution, process capability, project completion, and cost reduction.
• Support project planning, timeline management, technical risk assessment, and status reporting for assigned process development and manufacturing engineering projects.
• Promote a safety-first, compliance-driven, data-based, and continuous improvement mindset within manufacturing operations.

• Education:
  • Bachelor’s degree in Engineering, Biology, Life Sciences, or a related technical field required.
  • Master’s degree in Engineering, Life Sciences, Business Administration, or a related field preferred.
  • Lean Six Sigma Green Belt or Black Belt certification preferred.
• Experience:
  • 3+ years of experience in manufacturing engineering, process development, process engineering, quality engineering, or a related technical function within an ISO 13485, GMP, FDA-regulated, or similarly regulated environment.
  • Experience participating in cross-functional…