Overview:

Kuros Biosciences, Inc. is seeking a Process Development Engineer to join our core Operations team to support the build out and running of Kuros' newest manufacturing facility in Alpharetta, Georgia. The Process Development Engineer will bring their technical manufacturing, leadership, and project management skills to a dynamic and fast-growing biotech company. This key technical role will be responsible for 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 the design, optimization, and scale-up of manufacturing processes and is critical to ensuring efficient, safe, and high-quality production.

Key Responsibilities:

• 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. Create and manage design changes through Engineering Change Orders (ECO).
• 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 Order (ECO) implementation.
• 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 concept through commissioning and validation.
• Evaluate, select, and implement equipment and technology upgrades.
• Lead process development for new and existing products and support scale-up 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, yields, and reduce cost.
• Analyze instrument-manufacturing line 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.
  

Qualifications & Skills:

• 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 ISO13485 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
• Proficiency in data analysis tools and software such as minitab, PowerBI, Tableau
• Proficiency in ERP and Masterdata, preferably in Microsoft Dynamics 365
• Experience in developing and sustaining a Supplier Quality program that monitors supplier programs using KPIs such as PPM, SCARs, and OTD
• Experience in developing and continuously improving upon Quality KPI's such as First Pass Yield, NCR's, Inventory Accuracy, and Monitoring budget to fiscal year plan
  

Travel Requirement:

• Ability to travel US and international
  
  

Pay Range

$95,000—$115,000 USD

Physical Requirements and Work Conditions

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Mobility & Posture: May require occasional sitting, standing, walking, climbing, reaching, bending, or stooping.
• Lifting/Carrying: May require lifting and carrying items up to 50 pounds, depending on the role.
• Manual Dexterity: Frequent use of hands and fingers for typing, writing, grasping, and operating office or job-specific equipment.
• Driving: Some roles may require the ability to operate a motor vehicle for extended periods and maintain a valid driver's license.
  
  

Specific requirements may vary by role. Contact an HR representative for details related to the position.

About Us

Kuros Biosciences is on a mission to discover, develop and deliver innovative biologic technologies.

Our Credentials

With locations in the United States, Switzerland and the Netherlands, the company is listed on the SIX Swiss Exchange. The company's first commercial product, MagnetOsTM, is a unique advanced bone graft that has already been used across four continents. For more information on the company, its products and pipeline, visit kurosbio.com.

• Listing on the SIX Swiss Exchange under the symbol KURN
• A commercial & research footprint that spans >20 markets
• 4 teams of internationally renowned clinical and scientific expert advisers
• >25 orthobiologics-related patents
• >400 patients evaluated in Level I, randomized controlled clinical trials
• >20 well-controlled Level I-III clinical trials initiated, including 6 that are complete
• Level I evidence published in Spine
  
  

Kuros Biosciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Kuros Biosciences complies with GDPR and the California Consumer Privacy Act (CCPA). View our CCPA Notice here.