Process development engineer [h1.location_city]

Job Description

Job Description

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.

Key Responsibilities :

• 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.
Qualifications :
• Education :

Bachelor's degree in Engineering, Biology, or related field required. A Master's degree in related fields or an MBA, preferred.

3+ years in Manufacturing, Process or Quality Engineering in an ISO13485 regulated industry

Strong analytical and problem-solving skills

Experience in the identification of the 8 wastes, line balancing and performing theory of constraints

Travel Requirement :

Pay Range

$80,000—$90,000 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.

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

Our credentials

Kuros is a Swiss-headquartered biotech company, listed on the SIX Swiss Stock Exchange since 2016 (under symbol KURN). With additional operations in the Netherlands and the USA, we continue to grow our global team.

To deliver the ideal bone graft, you need the highest quality and quantity of scientific evidence behind it. We believe that this is a key differentiator for Kuros, given the urgent need to advance bone healing.

20 markets

25 orthobiologics-related patents

400 patients evaluated in Level I, randomized controlled clinical trials

20 well-controlled Level I-IV clinical trials initiated , including 6 that are complete1

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.