Headquartered in Brooklyn, New York, Cresilon, Inc. is a privately-held medical device company focused on hemostatic technologies that improve wound care and advance the standard of medical treatments. For more information, visit Cresilon.com. 

We are always looking for dynamic people to join our team as we dive into a range of challenges at the forefront of science and technology—to learn more about our openings please visit https://cresilon.workable.com/.

Cresilon

Software Engineer

Oversee process engineering activities for hemostatic medical devices utilizing hydrogel technology.

• Oversee all process engineering activities including process development/implementation process improvements, process scale-ups, process technology transfers, and process validations.
• Act as a technical thought leader in process engineering, facilities engineering, and equipment realization. Provide technical expertise and scientific leadership in troubleshooting, root cause analysis, and data trending toward continued manufacturing process and facility improvements.
• Play a lead role in technology identification, scale-up, and process characterization & validation, including successful process transfer and implementation.
• Support facilities engineering modifications as required for process implementation including impact to all aseptic manufacturing facility infrastructure, HVAC/major mechanical equipment, electrical, plumbing, roofing, utilities, and other infrastructure systems. Lead execution of regular facility shutdowns.
• Ensure all engineering projects, initiatives, and processes are in conformance with the organization's established policies and objectives and in adherence to OSHA, NFPA, and other applicable safety codes.
• Contributes to strategic planning by evaluating and projecting future process and facility needs, including proposing options to achieve them.
• Analyze facility needs, plans, and budgets for expenditures in collaboration with senior management. Manage the approved capital and facilities-related expense budget to ensure that all budgets and schedules are met.
• Ensure compliance with all applicable specifications, standard operating procedures (SOPs), and FDA regulations.
• Ensure that all budgets, schedules, and performance requirements are met.
• Improve product quality, yield and overall cost, working closely with internal personnel and external suppliers.
• Apply LEAN and Six Sigma principles to manufacturing operations, with an emphasis on a culture of continuous improvement.
• Document all cGMP activities following company policies, procedures, and applicable regulatory standards.
• Ensure effective selection, training, development, and performance management of the manufacturing team to meet business needs.
• Other duties may be assigned as deemed necessary by management.

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Cresilon