Process Development Engineer

 

Overview:

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.

Key Responsibilities: 

• 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.

Qualifications: 

• 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 technical projects, process improvement initiatives, or manufacturing launch activities preferred.
  • Experience supporting process validation, equipment qualification, manufacturing transfer, scale-up, continuous improvement, CAPA, NCR, deviation, and engineering change activities.
  • Medical device, biologics, life sciences, pharmaceutical, or regulated manufacturing experience preferred.
• Skills: 
  • Ability to independently execute technical assignments, manage priorities, and collaborate effectively within cross-functional project teams.
  • Strong technical knowledge of process development, manufacturing process validation, equipment qualification, process control, risk management, and regulated manufacturing documentation.
  • Hands-on experience with IQ/OQ/PQ, process validation, PFMEA, control plans, MSA, Gage R&R, attribute agreement analysis, Cpk analysis, root cause analysis, and corrective action methods.
  • Proficiency in Lean manufacturing and Six Sigma tools, including waste elimination, line balancing, theory of constraints, standard work, visual management, value stream thinking, DMAIC, and DMADV.
  • Strong analytical, troubleshooting, and data-based decision-making skills with the ability to translate technical findings into practical manufacturing improvements.
  • Ability to support multiple technical projects, timelines, priorities, and cross-functional stakeholders in a fast-paced manufacturing environment.
  • Excellent communication skills with the ability to interact effectively with Operations, Quality, R&D, Supply Chain, Maintenance, leadership, vendors, and global partners.
  • Proficiency with data analysis and reporting tools such as Minitab, Power BI, Tableau, or equivalent software.
  • Experience working with ERP, master data, BOMs, routings, and manufacturing system inputs; Microsoft Dynamics 365 experience preferred.
  • Working knowledge of manufacturing KPIs such as first pass yield, NCRs, CAPA effectiveness, process capability, inventory accuracy, throughput, cycle time, scrap, and on-time project execution.

Travel Requirement:

• Ability to travel domestic and international