Senior Process Engineer/Process Engineer II - Manufacturing - Cresilon : Job Details

Cresilon is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology. The company's plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives.

The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for our medical device products. This position plays a key role in ensuring that all manufacturing processes meet quality, compliance, and performance standards. The engineer will work closely with cross-functional teams including Quality, R&D, Regulatory, and Production developing, optimizing, and scaling manufacturing processes to improve yield, throughput, quality, and efficiency. The Process Engineer will have a strong operational, quality, and technical background. This is often a hands-on role working closely with the production team to train operators to new processes, troubleshoot equipment challenges, and write and execute qualifications and validations.

This is a full-time, on-site position, located in Brooklyn, New York. It is a multi-faceted role in a highly collaborative environment that will require creativity and focused execution in pursuit of maximizing production outputs and creating robust manufacturing processes.

Responsibilities:

• Design, develop, and optimize manufacturing processes for new and existing medical devices.
• Lead process development for new product introductions (NPI), from concept through validation and launch.
• Develop and refine manufacturing processes to reduce variation, increase yield, improve cycle times, and reduce cost.
• Evaluate and implement automation technologies to improve process consistency and throughput.
• Interface with external vendors and suppliers to specify new equipment, product or process requirements, or troubleshoot product issues.
• Analyze production data to identify trends, root causes, and opportunities for efficiency.
• Maintain and update validation documentation as part of lifecycle management.
• Ensure processes comply with applicable regulatory requirements and internal quality standards.
• Lead root cause investigations (CAPA, NCRs, SCARs) and implement corrective and preventive actions.
• Develop process documentation including standard operating procedures (SOPs), work instructions, pFMEAs, and equipment qualifications.
• Partner with R&D during design transfer to ensure design for manufacturability (DFM) and seamless product integration.
• Collaborate with Quality and Regulatory teams to support audits, inspections, and compliance initiatives.
• Provide technical leadership and mentorship to junior engineers and technicians (for Senior level).
• Monitor and analyze key process indicators (KPIs), quality metrics, and manufacturing data
• Specify, procure, and validate manufacturing equipment and tooling.
• Author and execute process validation protocols (IQ/OQ/PQ) in accordance with FDA and ISO 13485 standards.
• Train manufacturing personnel on new or revised processes and equipment.
• Provide ongoing floor support for manufacturing operations, helping to resolve technical issues in real time.
• Other duties may be assigned as deemed necessary by management.