Process Development Engineer

Overview

Contribute your technical manufacturing, leadership, and project management skills to a dynamic and fast‑growing biotech company. This key technical role will have responsibilities in supporting Kuros' manufacturing by creating and validating manufacturing processes, managing continuous improvement initiatives, authoring all associated manufacturing documentation, and maintaining compliance with our quality system. This role will lead to the design, optimization, and scale‑up of manufacturing processes and is critical to ensuring efficient, safe, and high‑quality production.

This is a full‑time, on‑site position.

• Join a core team of leaders to support the building of Kuros’ newest manufacturing facility in Alpharetta, Georgia.
• Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/PQ).
• While utilizing Lean manufacturing tools, create, maintain and improve production process, refining BOMs, workflow processes, PFMEAs and detailed work instructions.
• Create, design, develop, and optimize manufacturing processes to improve efficiency, yield, and product quality. Production of complex products with responsibilities including but not limited to:
  • Establish group and individual objectives, priorities, and metrics.
  • Ensure fulfillment of product development goals for Kuros projects.
  • Ensure production of products meets expected output.
  • Ensure quality requirements are fulfilled and maintained.
  • Maintain compliance with medical device quality system which includes leading and/or supporting corrective action preventative action initiatives (CAPAs), discrepant material disposition and implementation of Engineering Changes.
  • Develop and maintain detailed process documentation, including process flow diagrams (PFDs), SOPs, and batch records.
  • Ensure compliance with regulatory and safety standards (e.g., GMP, ISO, FDA, EH&S).
  • Support capital projects from concepts through commissioning and validation.
  • Evaluate, select, and implement equipment and technology upgrades.
  • Lead process development for new and existing products and support scale‑ups from R&D to full production.
  • Preventive maintenance of equipment and utilities and troubleshooting if needed.
  • Provide technical support for failure analysis and root cause investigation of product failures.
  • Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction, utilizing a DMAIC and DMADV structure.
  • Plan, budget and staff projects, tracking performance throughout.
  • Manage and allocate team resources over multiple projects.
  • Provide and solicit resources to and from other teams as necessary.
  • Work with Quality group to ensure that the team follows appropriate Good Manufacturing Processes (GMP), design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures.
  • Improve product quality, yield, and reduce costs.
  • Analyze instrument‑manufacturing lines from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
  • Provide production line support for day‑to‑day engineering issues on core equipment.
  • Provide technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns.

• Education: Bachelor’s degree in Engineering, Biology, or related field required. A Master’s degree in related fields or an MBA, preferred.
  • Lean Six Sigma Green Belt or Black Belt Certification preferred
• Experience:
  • 3+ years in Manufacturing, Process or Quality Engineering in an ISO
    13485 regulated industry
  • Experience with regulatory environments such as GMP, FDA, or ISO standards
• Skills:
  • Strong analytical and problem‑solving skills
  • Excellent communication and interpersonal abilities
  • Proven experience in performing IQ, OQ, PQ's
  • Proficiency in process control, lean methodologies and Six Sigma tools
    • Experience in the identification of the 8 wastes, line balancing and performing theory of constraints
    • Experience…