Cresilon jobs in New York, NY

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. Learn more about the company at ***************** The Production Technician I is responsible for the aseptic manufacturing of Cresilon's products for the animal health industry. The Production Technician II will be trained in clean room operations, aseptic techniques, and must demonstrate the ability to successfully pass gowning qualifications. The position involves operating simple and complex processing equipment, routine sanitization of cleanroom facilities, and manual cleaning of equipment. The ideal candidate will have a proven track record of steady progress in a similar manufacturing environment and must possess a willingness to learn all equipment and jobs in the assigned manufacturing and sanitation of clean room facilities as required. Production Technicians are also responsible for the quality of products produced by ensuring compliance with local, State and Federal regulations, including current Good Manufacturing Practices (cGMP). Perform line clearance of assigned production areas as required. Perform equipment set up and disassembly activities. Operate production, assembly and testing equipment, including heat sealers, bar code scanners, weighing scales, tumblers, autoclaves, filling equipment, and packaging equipment. Formulate, fill, and pouch product in accordance with SOPs. Troubleshoot all operating deviations and issues and coordinate with other functions when required. Report both machine and operating deviations to area supervisor or designee. Perform routine, preventative maintenance on equipment. Perform cleaning and disinfection of the manufacturing spaces. Perform cleaning and sterilization of manufacturing equipment. Perform visual inspection of components and/or product in accordance with SOP's and cGMP's. Perform sampling, intermediate, and finished goods packaging as per SOPs. Package and ship raw materials for sterilization. Perform material receiving, staging, material movements, and material replenishment as per SOPs. Transport samples, materials, and equipment between multiple facilities. Complete data entry and generate reports for material inventory movements. Complete and maintain applicable logbooks and batch record paperwork as required and in accordance with GMP and GDP standards. Maintain a clean production environment during shift. Report all actual, near misses and potential accidents for further investigation. Take immediate action to resolve any near miss situations. Assist in investigation of all actual, near misses and potential accidents. Provide information to troubleshoot and take initiative to resolve operational issues independently. Assist in project commissioning and validation activities, as necessary. Prepare samples or prototypes as required for testing, or other evaluations Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process. Complete all required trainings: Read and Understand (TM1), Computer Based Training with Quiz (TM2), Instructor Led (TM3/TM4), and On-the-Job Trainings (TM5). Oversee training of junior employees on production processes as assigned. Ensure proper communication and handling over of shift duties. Support Environmental and Personnel Monitoring (EM/PM) activities as directed. Responsibilities may include other duties as assigned and as required Requirements HS Diploma or Equivalent with 2+ years of relevant manufacturing experience in the pharmaceutical, biotechnology, or medical device industry OR 2 or 4 year degree with 0+ years of relevant experience. Ability to read, understand, and execute written work instructions. Ability to complete documentation accurately. Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals Ability to become gowning qualified to work in a cleanroom environment. Ability to problem solve and achieve business objectives. Ability to adapt training approach. Willingness to be flexible, and open minded to new processes or changes in direction. Team oriented, building relationships with peers and managers in a proactive manner. Excellent verbal and written communication skills. Proficient in Microsoft Office (Word, Excel, Outlook). Must be able to work overtime and/or second shift when needed. Benefits Paid Vacation, Sick, & Holidays Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage Company Paid Life and Short-Term Disability Coverage Work/Life Employee Assistance Program 401(k) & Roth Retirement Savings Plan with company match up to 5% Monthly MetroCard Reimbursement $20-24/hr Cresilon 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. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

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. Learn more about the company at ***************** The R&D Formulation Manager/Principal Scientist will lead the design, development, and implementation of novel formulations and polymer materials for use in medical devices, ensuring all activities meet quality and regulatory standards. This role involves providing expertise in formulation development, building and optimizing internal capabilities to deliver innovative and efficient solutions, and ensuring alignment with the company's long-term technical vision to create a strong pipeline of customer-focused innovations. Key responsibilities include developing and characterizing formulations, recruiting and onboarding talent, managing technical collaborations with external suppliers and vendors, and integrating formulations into scalable manufacturing processes, whether in-house or through CDMOs. This role operates in a collaborative, cross-functional environment, requiring flexibility, a strong focus on scientific formulation, and a drive to explore new technologies and techniques in pursuit of robust, innovative materials and products. This is a senior technical role overseeing a small team. The R&D Formulation Manager/Principal Scientist is expected to be a subject matter expert in areas including polymer material science, formulation strategies, analytical chemistry, and biomaterial interactions with biological systems. They are responsible for ensuring high standards in research practices. They are responsible for leading the creation of documentation required for regulatory submissions, developing strategies for grants and publications, and securing non-dilutive funding through grant opportunities. They will report to the Vice President Technology. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities Lead, staff, and manage formulation development teams and their efforts across multiple parallel product development opportunities, to launch new commercially successful products. Provide sound scientific leadership, monitoring, and coaching through the initiation, planning and execution their team's overall activities. Create and lead experimentation for exploratory and/or product development research with focus on polymeric materials and their use. Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures. Lead material/design/process changes through design control process, with well-documented research/analyses. Review and author protocols and reports including development studies and design verification/validation activities. Develop and implement investigations into new technologies and capabilities, partnering with business development, that advance research team and company objectives. Lead efforts in chemical and mechanical property evaluation to assess the desirability of process or formulation changes. Develop test method capabilities to support R&D (exploratory research, product development) and production test requirements. Develop unique, proprietary (and ideally patentable) intellectual property that yields competitive advantage. Lead and participate in voice-of-customer (VOC) labs and influence go-to-market strategies. Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication. Work as part of a cross-functional team to develop, verify, and validate product designs through bench, in-vitro, and in-vivo testing and other assessments. Ensure an effective documentation system is in place and utilized throughout the development process inclusive of R&D lab notebooks, design reviews, test methods, and test reports. Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions, Act as research liaison between R&D and Quality Control to define product specifications. Maintain active dialogue with Manufacturing to ensure successful technology transfer and process development, including the review of research-related documents Provide guidance and support to commercial teams, support introduction of new technologies with development of presentations, sales tools, formulations and applications data. Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company. Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Provide other project, product, or leadership support as needed to support Cresilon's business objective. Requirements Required Qualifications Master's degree in Chemistry, Materials Science, Chemical Engineering, Polymer Science, or a closely equivalent discipline. A minimum of 10 years of research experience in developing and utilizing polymeric materials, biomaterials, or other complex materials toward product/application development and their manufacture, with at least 5 years in a non-academic setting. A minimum of 2 years of direct management experience. Adept experimentalist with hands-on research experience with polymers, coagulation chemistry, and materials science of complex systems, including the development of structure-property performance relationships in designing and characterizing these materials. Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements, along with a fundamental understanding of the chemistry that drives the performance required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively. Direct experience in new product development from concept to regulatory approval through launch. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies is required. Excellent verbal and written communication skills, with the ability to lead in a dynamic and collaborative environment is required. Highly organized and detail-oriented, with the ability to extract key facts from complex information and create/present clear and concise technical documentation is required. Demonstrated ability to lead and inspire teams and develop and mentor individuals, and allocate resources strategically and according to the portfolio priorities. Requires strong leadership and organizational skills with a strong attention to detail and multi-tasking skills while simultaneously keeping overall “big picture” view of projects, priorities, and strategies. Experience working under pressure with tight timelines, with the ability to maintain a sense of priorities, focus, urgency, and delivery. Strong working knowledge of Microsoft Office. Legal authorization to work in the United States. Preferred Qualifications Ph.D. in a relevant discipline is strongly preferred. Experience developing and commercializing products in a highly regulated environment Medical device development experience. Demonstrated expertise in the use, development, and qualificication of material characterization techniques, including rheological, thermal, mechanical, spectroscopic, microscopic, and other chemical compositional methods. Strong understanding of medical device regulatory requirements for Class II and III medical devices (e.g., 21 CFR Part 820), cGLP/cGMP, and related standards (e.g., ISO 13485). Strong understanding of cGMP, ICH guidelines Six sigma green belt or black belt certification. Experience with executing a grant and publication submission strategy, knowledge of and strong track record with SBIR submissions to multiple agencies, including NIH and DOD is strongly preferred. Demonstrated experience in Project Management and Product Lifecycle Management practices, and the ability to lead multiple projects simultaneously. Excellent problem-solving skills and a proactive approach to addressing formulation challenges. Cresilon 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. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits BENEFITS Competitive annual base salary range of $130,000 - $180,000, depending upon qualifications. Paid Vacation, Sick, & Holidays Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage Company Paid Life and Short-Term Disability Coverage Work/Life Employee Assistance Program Monthly MetroCard Reimbursement 401(k) & Roth Retirement Savings Plan with company match up to 5%

The Production Supervisor leads a sound, efficient, safe, and effective production operation and implements our vision for this business-critical function at Cresilon. The Production Supervisor oversees optimal and cost-effective aseptic manufacturing practices in a fast-paced environment through collaboration with stakeholders, production engineers and technicians. The Production Supervisor should have a strong operational, quality, compliance, and technical background. This is often a hands-on role working closely with the production team to troubleshoot process and equipment challenges. They must ensure production processes comply with local, State, and Federal regulations, including current Good Manufacturing Practices (cGMP). 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 strong leadership and focused execution in pursuit of maximizing production outputs, on-time customer shipping and overall robust manufacturing processes. Shift Timing: Second shift is currently defined as 11:00am-7:30pm. This timing will shift to 3:00pm-11:30pm within ~6 months. During training, the 2nd shift production supervisor will occasionally be required to work 1st shift (7:00am-3:30pm). Hours may vary depending on company requirements. Responsibilities: · Organizes, and leads production operations and associated production activities to drive production target while maintaining quality, cost, and customer service expectations within a safe working environment. · Manages a team of production technicians. · Manages production KPIs including, labor budget, yield, and OEE, and ensures target production metrics are met. · Communicates production results and challenges. Troubleshoots and implements solutions to issues quickly and efficiently to avoid potential delays. · Ensures all tasks associated with manufacturing operations are performed in accordance to cGMP and SOPs, and ensures batch record requirements are completed in a timely manner. · Supervises all aspects of production, including the assembly, disassembly, cleaning, and storage of manufacturing equipment, the cleaning of the cleanroom facility, formulation, filling/finishing, and product shipping operations related to the second shift of technicians. · Acts as a subject matter expert on Manufacturing Practices, including in aseptic behaviors and practices. · Implements continuous improvement, leveraging expertise in Six Sigma, Lean, or Toyota Production System (TPS) approaches. · Adheres to all workplace safety laws, regulations, standards and practices and actively advances a culture of safety within their team and organization. · Resolves or escalates any problem occurring in the area that affects product quality, safety, and other aspects of production line performance. · Demonstrates the ability to properly operate equipment, perform equipment set-up/change-over/cleanups, assist in preventative maintenance and troubleshoots equipment problems to achieve optimum production targets. · Establishes a working environment that fosters participation within and between teams. · Hires, trains, develops, disciplines, and discharge production technicians. · Develops, mentors, and supports production technicians in assisting continuous improvement efforts, improving employee engagement, and supporting business growth. · Ensures compliance with Quality Assurance and Quality Control requirements and participates in timely investigations and implementation of corrective and preventative action. · Ensures records are maintained per SOPs and cGMP requirements. · Generates production batch procedural documentation, manages change assessments, and nonconformance reports. · Creates, updates, reviews, and maintains production-related SOPs. · Reviews and approves documents, including standard operating procedures, batch records, and material specifications. · Leads the execution of and training for newly transferred or existing products and processes. · Leads and assists with the continuous improvement of production operations and procedural documentation. · Organizes and leads initial and on-going training of new and existing personnel. · Maintains appropriate inventory of production supplies and materials. · Ensures on time delivery and quality through accurate work order completions, on time shipping, and accuracy of inventory consumption. · Other responsibilities as required or assigned by management. Requirements Education: Bachelor's degree with a focus on science or engineering is preferred. Qualifications: · 3+ years of relevant cGMP manufacturing experience with a minimum of one year managing hands-on manufacturing operations with direct supervisor responsibility. · Experience in GMP cleanroom operations, including aseptic processing. · Strong leadership skills with the ability to motivate staff members and develop a culture of operational excellence · Experience in supporting regulatory inspections and audit readiness activities is required. · Experience with lean manufacturing or six sigma. · Working knowledge of quality management systems. · Previous experience in any of the following areas is preferred: formulation, fill and finish operations, and packaging. · Ability to multitask and prioritize work, while remaining detail oriented. · Team oriented with the ability to build relationships and influence and/or enforce decisions with peers and management in a proactive manner. · Strong leadership skills with a proven ability to build, motivate, and maintain a high performing, cohesive team with the ability to inspire passion and commitment and lead and facilitate operational and cultural change initiatives. · Demonstrated experience training technical personnel is required. · Adept at motivating others in a deadline driven environment. · Proven history of owning quality and efficiency KPIs and driving them in a positive direction · Proven leadership skills, capability and ability to mentor, coach, and develop a team and other associates · Organizational and time management skills with the ability to prioritize a variety of tasks/projects. · Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. · Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. · Excellent verbal and written communication skills required. · Demonstrated understanding of aseptic processing and microbial control concepts preferred. · Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint required. · Legal authorization to work in the United States is required. Physical Requirements: · Ability to become gowning qualified to work in a cleanroom environment. · Ability to climb, balance, stoop, reach, stand, and walk. · Ability to bend, twist, push, lift, and grasp. · Ability to speak, listen, and understand verbal and written communication in English. · Ability to pass respirator fit test. · Ability to work for extended periods of time with appropriate respiratory equipment. · Manual dexterity to perform delicate manipulations. · Ability to perform repetitive motions, including the substantial movement of wrists, hands, and or fingers. · Ability to lift 50 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. · Visual acuity to perform close activities such as: reading, writing, and analyzing; and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations Benefits · Competitive annual base salary range of $90,000 - $120,000, depending upon job level and qualifications. · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement Cresilon 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. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

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. Learn more about the company at ***************** Next summer, Cresilon is looking to bring on interns from diverse fields in order for them to gain exposure into the industry. There will be technical and non-technical internships available, which will focus on a specific project. Candidates will be exposed to all aspects of the industry regardless of their placement. The internship is a 10-week onsite program beginning on 1 June 2026. Compensation will be fixed at $30.00/hour for 40 hours/week. Part time opportunities are also available. The application period closes on 27 February 2026. There are ten internship categories available. Please indicate your Top 2 choices in your attached cover letter: 1. Manufacturing Operations and Supply Chain : Interns will assist with supply chain optimization, production planning, supply planning, demand planning, logistics, optimization of processes / process flows, creation and revision of Standard Operating Procedures (SOPs) and batch records, and equipment installation and qualification. Opportunities for compensated travel to conferences and other industry related events exist. 2. Quality Assurance : Interns will assist in establishing the Quality Management System, which serves as the backbone of all quality and regulatory requirements at Cresilon. Interns will help in maintaining the central document control system, implementing OSHA requirements, participating in inspections and reporting any non-conformances. Opportunities for compensated travel to conferences and other industry related events exist. 3. Quality Operations & Compliance : The intern will provide support to the Quality Operations and Compliance department in maintaining and improving the Quality Management System (QMS). This position will offer valuable exposure to ISO 13485 and FDA 21 CFR 820 requirements while assisting in day-to-day compliance activities. The intern's contribution will improve documentation practices, streamline review processes, and boost departmental efficiency while providing them with hands-on support. Opportunities for compensated travel to conferences and other industry related events exist. 4. R&D Formulation : Interns will assist with conducting routine research and development on the subject of polymer formulation development, physical and chemical characterization of polymer materials, structure-property performance in-vivo and process scale-up. Interns will write up and present findings. Opportunities for compensated travel to conferences and other industry related events exist. 5. R&D Process Development : Interns will assist with process development, equipment installation and qualification, creation and revision of Standard Operating Procedures (SOPs), fixture design, and process scale-up. Opportunities for compensated travel to conferences and other industry related events exist. 6. R&D Product Development : Interns will assist with conducting routine research and development on the subject of designing, testing, and improving delivery devices for Cresilon's suite of products. Interns will write up and present findings. Opportunities for compensated travel to conferences and other industry related events exist. 7. Quality Control (Microbiology/Chemistry) : Interns will assist with verifying conformance to in-process specifications and proposing and implementing QC assays. This program will involve working with aseptic technique and interfacing with the manufacturing team. Opportunities for compensated travel to conferences and other industry related events exist. 8. Data Analytics : Interns will assist with identifying new/existing data sources, consolidating and merging redundant datasets, creating and populating databases, designing and automating data entry and data reporting functions, and building extensive data analytics dashboards for continuous monitoring of the company's quality and manufacturing processes. Opportunities for compensated travel to conferences and other industry related events exists. 9. Regulatory Affairs : The Regulatory Affairs Intern will support Cresilon's Regulatory Affairs team in advancing global compliance and market access for its medical device products. This internship provides a hands-on learning experience, with a primary focus on Regulatory Intelligence and global strategic research across multiple markets. 10. Quality Engineering Job Description: Interns will assist with product realization efforts, including design verification & validation, execute software validation activities, including specifications and qualification protocols. This position will provide hands on experience with conducting quality risk assessments as well as authoring risk documents. Requirements Requirements for Research and Development Formulation Internship: Background in Chemistry, Biochemistry, Chemical Engineering, Materials Engineering, or similar Prior lab experience required. Graduate-level coursework preferred. Requirements for R&D Process Development/Engineering Internship: Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or similar Prior lab experience required. Industry experience preferred. Requirements for R&D Product Development Internship: Background in Mechanical Engineering, Biomedical Engineering, or similar Prior lab experience required. Graduate-level coursework preferred. Requirements for Manufacturing Internship: Background in Supply Chain Management, Industrial Engineering, Chemical Engineering, or similar Graduate-level coursework and/or industry experience preferred Requirements for Quality Assurance/Quality Operations & Compliance Internship: Background in Chemistry, Biology, Quality Assurance, or similar Prior lab experience preferred Requirements for Quality Control Internship: Background in Chemistry, Biology, Engineering, or similar Prior lab experience required Requirements for Data Analytics Internship: Background in Computer Science, Data Science, or similar Knowledge of SQL, VBA, Power Query, and/or Python preferred. Knowledge of statistics preferred Requirements for Regulatory Affairs Internship: Currently pursuing or recently completed a Master's degree in Regulatory Affairs or a related field (Medical Device coursework preferred) Strong theoretical foundation in regulatory principles and frameworks Prior industry experience is a plus but not required A strong passion for regulatory science and a high level of curiosity and eagerness to learn are essential for success in this role. Requirements for Quality Engineering Internship: Currently pursuing Bachelor's or Master's program in Engineering, preferably Biomedical Engineering or Chemical Engineering. Cresilon 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. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits Interns will receive an unlimited Monthly MTA metro-card for the duration of the program. Free Food & Snacks Happy Hours Health Care Plan (Medical, Dental & Vision), FSA (Healthcare & Commuter Benefits) for eligible employees working 30 + hours a week Training The salary for this role is $30/hr

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. Learn more about the company at ***************** Description: The Senior Medical Device Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements. They will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards. The person in this position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required. The position has a scientific focus that includes formulation development, product performance characterization, and implementation, including prototype design and fabrication, and data generation through designed experiments. The Senior Medical Device Engineer is expected to aspire for excellence with a bias toward action, willing to roll up their sleeves, get hands-on, and do what's necessary to move projects forward in a fast-paced environment. They are committed to designing and developing products that dominate the marketplace and improve healthcare by partnering with our customers to drive purposeful innovation, resulting in best-in-class products. The Medical Device Engineer will work with a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of product innovation and robustness. Role level is contingent on experience, but this is not an entry level role.. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use. Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety. Lead cross-functional teams to develop new products, address design issues, and maintain existing designs. Apply strong problem-solving skills to find solutions to complex problems. Work independently to plan and schedule own activities necessary to meet project timelines. Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success. Lead the creation of design history file documentation through the new product development process. Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications. Generate technical protocols/reports to support device safety and efficacy. Invent/create concepts and designs and submit invention disclosures. Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses. Author protocols and reports including development studies and design verification/validation activities. Develop and execute test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes. Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures. Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs. Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication. Maintain a laboratory notebook and other technical documentation to required GLP/GMP guidelines. Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions, Provide support to marketing and sales team, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company. Manage part-time staff as a research leader and mentor for ongoing research projects. Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Provide other project or product support as needed in order to support Cresilon's business objective. Responsibilities may include other duties as assigned and as required. Requirements Required Qualifications BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline. A minimum of 5+ years of product development experience is required. A minimum of 4 years of hands-on experience in new product research and development in a cGMP-regulated industry is required (work experience in the Medical Device field is strongly preferred) Adept experimentalist with hands-on experience in product development of medical devices and their safety/efficacy characterization in an R&D environment. Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans. Experience leading complex product development initiatives from concept through product launch/release. Good working knowledge of anatomy and surgical procedures is required. Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite the completion of critical project tasks Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills. Requires strong leadership skills, excellent written and verbal communication and presentation skills. Working knowledge of FDA requirements as per 21 CFR 820, ISO 9001, ISO 13485:2003, and ISO 14971:2007. Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP) Good understanding of statistical tools and validation/verification techniques. Proficiency in the use of Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required. Legal authorization to work in the United States is required. Preferred Qualifications An advanced degree (MS or Ph.D.) is strongly preferred. Hands-on experience in product development with Class II and Class III medical devices. Experience developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs. Experience with IDE and PMA submissions. Six-Sigma green belt or black belt certification Cresilon 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. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits Competitive annual base salary range of $100,000 - $160,000, depending upon job level and qualifications Paid Vacation, Sick, & Holidays Monthly MetroCard Reimbursement 401(k) & Roth Retirement Savings Plan with company match up to 5% Work/Life Employee Assistance Program Company Paid Life and Short-Term Disability Coverage Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

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. Learn more about the company at ***************** Description: 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 Requirements · Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field. · Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years process development, design, and process implementation required. · Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years hands-on experience in process development, design, and process implementation required, preferably in medical device, pharmaceutical, or biotech manufacturing. · Understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. · Proven experience with process validation (IQ/OQ/PQ), root cause analysis, and CAPA. · Proven experience in process design, optimization, and troubleshooting. · Experience implementing process and quality improvements into manufacturing or CMO · Strong analytical and problem-solving skills. · Ability to multitask and prioritize work, while remaining detail-oriented. · Demonstrated experience training technical personnel. · Familiarity with data analysis tools and manufacturing software. · Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. · Experience with Lean Manufacturing, Six Sigma, or similar methodologies. · Hands-on experience with manufacturing processes such as formulation, fill and finish, packaging, and CIP. · Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. · Demonstrated experience managing third-party vendors and service providers. · Demonstrated ability to work independently as well as be a strong team contributor. · Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. · Excellent verbal and written communication skills required. · Ability to become gowning qualified to work in a cleanroom environment. · Ability to speak, listen, and understand verbal and written communication in English. · Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. · Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint. · Legal authorization to work in the United States. Preferred Qualifications: · Master's degree in Engineering or related field. · Experience in medical device or pharmaceutical · 3+ years of relevant cGMP manufacturing experience. · Experience in cleanroom operations, including aseptic processing. · Experience with CMOs. · Significant experience with CAD software · Experience in supporting regulatory inspections and audit readiness. · Six Sigma certification (Green or Black Belt) or Lean Manufacturing experience. · Mechanical/Electrical knowledge with the ability to troubleshoot equipment · Strong leadership skills with the ability to influence and motivate a cross-functional team · Organizational and time management skills with the ability to prioritize a variety of tasks/projects. · Demonstrated understanding of aseptic processing and microbial control concepts. Benefits Competitive annual base salary range of $90,000 - $150,000, depending upon job level and qualifications. · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement Cresilon 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. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

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. Learn more about the company at ***************** Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols. Create and execute product/process enhancement, and new product/process development plans. Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results, Author protocols and reports including engineering studies and design verification/validation activities. Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes. Prepare samples as required for manufacturing, testing, or other evaluations and data analysis. Participate in voice-of-customer (VOC) labs and other user needs assessments. Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes. Support process and product transfers to manufacturing or CDMOs. Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines. Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory. Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions. Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data. Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Provide other project or product support as needed to support Cresilon's business objectives. Requirements Required Qualifications Education: BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline. Minimum 4+ years previous experience in an industrial environment with a BS degree. (2 years minimum experience if advanced degrees). Proficiency as an adept experimentalist with hands-on experience in the product and process development of polymeric materials and their characterization in an R&D or manufacturing environment. Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills. Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time. Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills. Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements. Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required. Requires excellent written and verbal communication and presentation skills. Legal authorization to work in the United States is required. Physical Requirements include: Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training. Wear Appropriate Personal Protective Equipment (PPE): Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment. Ability to speak, listen, and understand verbal and written communication. Possesses hand-eye coordination and manual dexterity for delicate manipulations. Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects. Visual acuity is required for performing close and distant activities. Preferred Qualifications An advanced technical degree (MS or PhD). ·Lab experience in an industry setting within cGMP-regulated environments. Prior experience developing processes and scaling these up into manufacturing or CDMO Mechanical/electrical knowledge with the ability to troubleshoot processing equipment Six Sigma green belt or black belt certification preferred. Experience implementing process and quality improvements in a manufacturing environment Work experience with the medical device or pharmaceutical industries Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200. Working knowledge of FDA requirements as per 21 CFR 820. Cresilon 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. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits Competitive annual base salary range of $70,000 - $120,000, depending upon job level and qualifications Paid Vacation, Sick, & Holidays Monthly MetroCard Reimbursement 401(k) & Roth Retirement Savings Plan with company match up to 5% Work/Life Employee Assistance Program Company Paid Life and Short-Term Disability Coverage Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

The Quality Assurance Technician is responsible for routine inspection and testing of raw materials and components as well as of final product for Cresilon's products in the Animal and Human Health industries. This position requires a strong attention to detail as the individual will be responsible for identifying deviations in product quality or safety and ensuring compliance with local, state, and federal regulations, including current Good Manufacturing Practices (cGMP). Position is for 2nd shift. Responsibilities: Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager. Perform line clearance activities and in-process inspections. Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below) Transfer materials between facilities (see lifting requirements below) Facility 1 of 2: 122 18th Street, Brooklyn, NY 11215 Facility 2 of 2: 87 35th Street, Suite 603/604/6R, Brooklyn, NY 11232 Operate testing equipment such as force testers, torque testers, and balances. Report all deviations in product, components, raw materials, and equipment per their relevant procedures Perform document control activities, including but not limited to printing logbooks and batch records. Transcribe data into digital systems for tracking Quality Metrics. Batch record review & support routine batch disposition Requirements Education: High School Diploma or Equivalent (2- or 4-year degree in Engineering, Science, or Technology/Biotechnology preferred) Required experience in GMP and FDA regulated environments (ISO 13485:2016 preferred) Ability to be Gowning Qualified per Cresilon's SOP. 1 year experience in regulated industry highly desirable Ability to lift, walk, stand, reach, pull and push Benefits · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement The salary for this role is $25/Hour Cresilon 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. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job Description 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. Learn more about the company at ***************** The R&D Formulation Manager/Principal Scientist will lead the design, development, and implementation of novel formulations and polymer materials for use in medical devices, ensuring all activities meet quality and regulatory standards. This role involves providing expertise in formulation development, building and optimizing internal capabilities to deliver innovative and efficient solutions, and ensuring alignment with the company's long-term technical vision to create a strong pipeline of customer-focused innovations. Key responsibilities include developing and characterizing formulations, recruiting and onboarding talent, managing technical collaborations with external suppliers and vendors, and integrating formulations into scalable manufacturing processes, whether in-house or through CDMOs. This role operates in a collaborative, cross-functional environment, requiring flexibility, a strong focus on scientific formulation, and a drive to explore new technologies and techniques in pursuit of robust, innovative materials and products. This is a senior technical role overseeing a small team. The R&D Formulation Manager/Principal Scientist is expected to be a subject matter expert in areas including polymer material science, formulation strategies, analytical chemistry, and biomaterial interactions with biological systems. They are responsible for ensuring high standards in research practices. They are responsible for leading the creation of documentation required for regulatory submissions, developing strategies for grants and publications, and securing non-dilutive funding through grant opportunities. They will report to the Vice President Technology. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities Lead, staff, and manage formulation development teams and their efforts across multiple parallel product development opportunities, to launch new commercially successful products. Provide sound scientific leadership, monitoring, and coaching through the initiation, planning and execution their team's overall activities. Create and lead experimentation for exploratory and/or product development research with focus on polymeric materials and their use. Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures. Lead material/design/process changes through design control process, with well-documented research/analyses. Review and author protocols and reports including development studies and design verification/validation activities. Develop and implement investigations into new technologies and capabilities, partnering with business development, that advance research team and company objectives. Lead efforts in chemical and mechanical property evaluation to assess the desirability of process or formulation changes. Develop test method capabilities to support R&D (exploratory research, product development) and production test requirements. Develop unique, proprietary (and ideally patentable) intellectual property that yields competitive advantage. Lead and participate in voice-of-customer (VOC) labs and influence go-to-market strategies. Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication. Work as part of a cross-functional team to develop, verify, and validate product designs through bench, in-vitro, and in-vivo testing and other assessments. Ensure an effective documentation system is in place and utilized throughout the development process inclusive of R&D lab notebooks, design reviews, test methods, and test reports. Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions, Act as research liaison between R&D and Quality Control to define product specifications. Maintain active dialogue with Manufacturing to ensure successful technology transfer and process development, including the review of research-related documents Provide guidance and support to commercial teams, support introduction of new technologies with development of presentations, sales tools, formulations and applications data. Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company. Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Provide other project, product, or leadership support as needed to support Cresilon's business objective. Requirements Required Qualifications Master's degree in Chemistry, Materials Science, Chemical Engineering, Polymer Science, or a closely equivalent discipline. A minimum of 10 years of research experience in developing and utilizing polymeric materials, biomaterials, or other complex materials toward product/application development and their manufacture, with at least 5 years in a non-academic setting. A minimum of 2 years of direct management experience. Adept experimentalist with hands-on research experience with polymers, coagulation chemistry, and materials science of complex systems, including the development of structure-property performance relationships in designing and characterizing these materials. Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements, along with a fundamental understanding of the chemistry that drives the performance required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively. Direct experience in new product development from concept to regulatory approval through launch. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies is required. Excellent verbal and written communication skills, with the ability to lead in a dynamic and collaborative environment is required. Highly organized and detail-oriented, with the ability to extract key facts from complex information and create/present clear and concise technical documentation is required. Demonstrated ability to lead and inspire teams and develop and mentor individuals, and allocate resources strategically and according to the portfolio priorities. Requires strong leadership and organizational skills with a strong attention to detail and multi-tasking skills while simultaneously keeping overall “big picture” view of projects, priorities, and strategies. Experience working under pressure with tight timelines, with the ability to maintain a sense of priorities, focus, urgency, and delivery. Strong working knowledge of Microsoft Office. Legal authorization to work in the United States. Preferred Qualifications Ph.D. in a relevant discipline is strongly preferred. Experience developing and commercializing products in a highly regulated environment Medical device development experience. Demonstrated expertise in the use, development, and qualificication of material characterization techniques, including rheological, thermal, mechanical, spectroscopic, microscopic, and other chemical compositional methods. Strong understanding of medical device regulatory requirements for Class II and III medical devices (e.g., 21 CFR Part 820), cGLP/cGMP, and related standards (e.g., ISO 13485). Strong understanding of cGMP, ICH guidelines Six sigma green belt or black belt certification. Experience with executing a grant and publication submission strategy, knowledge of and strong track record with SBIR submissions to multiple agencies, including NIH and DOD is strongly preferred. Demonstrated experience in Project Management and Product Lifecycle Management practices, and the ability to lead multiple projects simultaneously. Excellent problem-solving skills and a proactive approach to addressing formulation challenges. Cresilon 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. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits BENEFITS Competitive annual base salary range of $130,000 - $180,000, depending upon qualifications. Paid Vacation, Sick, & Holidays Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage Company Paid Life and Short-Term Disability Coverage Work/Life Employee Assistance Program Monthly MetroCard Reimbursement 401(k) & Roth Retirement Savings Plan with company match up to 5%

The Production Supervisor leads a sound, efficient, safe, and effective production operation and implements our vision for this business-critical function at Cresilon. The Production Supervisor oversees optimal and cost-effective aseptic manufacturing practices in a fast-paced environment through collaboration with stakeholders, production engineers and technicians. The Production Supervisor should have a strong operational, quality, compliance, and technical background. This is often a hands-on role working closely with the production team to troubleshoot process and equipment challenges. They must ensure production processes comply with local, State, and Federal regulations, including current Good Manufacturing Practices (cGMP). 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 strong leadership and focused execution in pursuit of maximizing production outputs, on-time customer shipping and overall robust manufacturing processes. Shift Timing: Second shift is currently defined as 11:00am-7:30pm. This timing will shift to 3:00pm-11:30pm within ~6 months. During training, the 2nd shift production supervisor will occasionally be required to work 1st shift (7:00am-3:30pm). Hours may vary depending on company requirements. Responsibilities: * Organizes, and leads production operations and associated production activities to drive production target while maintaining quality, cost, and customer service expectations within a safe working environment. * Manages a team of production technicians. * Manages production KPIs including, labor budget, yield, and OEE, and ensures target production metrics are met. * Communicates production results and challenges. Troubleshoots and implements solutions to issues quickly and efficiently to avoid potential delays. * Ensures all tasks associated with manufacturing operations are performed in accordance to cGMP and SOPs, and ensures batch record requirements are completed in a timely manner. * Supervises all aspects of production, including the assembly, disassembly, cleaning, and storage of manufacturing equipment, the cleaning of the cleanroom facility, formulation, filling/finishing, and product shipping operations related to the second shift of technicians. * Acts as a subject matter expert on Manufacturing Practices, including in aseptic behaviors and practices. * Implements continuous improvement, leveraging expertise in Six Sigma, Lean, or Toyota Production System (TPS) approaches. * Adheres to all workplace safety laws, regulations, standards and practices and actively advances a culture of safety within their team and organization. * Resolves or escalates any problem occurring in the area that affects product quality, safety, and other aspects of production line performance. * Demonstrates the ability to properly operate equipment, perform equipment set-up/change-over/cleanups, assist in preventative maintenance and troubleshoots equipment problems to achieve optimum production targets. * Establishes a working environment that fosters participation within and between teams. * Hires, trains, develops, disciplines, and discharge production technicians. * Develops, mentors, and supports production technicians in assisting continuous improvement efforts, improving employee engagement, and supporting business growth. * Ensures compliance with Quality Assurance and Quality Control requirements and participates in timely investigations and implementation of corrective and preventative action. * Ensures records are maintained per SOPs and cGMP requirements. * Generates production batch procedural documentation, manages change assessments, and nonconformance reports. * Creates, updates, reviews, and maintains production-related SOPs. * Reviews and approves documents, including standard operating procedures, batch records, and material specifications. * Leads the execution of and training for newly transferred or existing products and processes. * Leads and assists with the continuous improvement of production operations and procedural documentation. * Organizes and leads initial and on-going training of new and existing personnel. * Maintains appropriate inventory of production supplies and materials. * Ensures on time delivery and quality through accurate work order completions, on time shipping, and accuracy of inventory consumption. * Other responsibilities as required or assigned by management.

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. Learn more about the company at ***************** Description: We are seeking a proactive, resourceful, and detail-oriented Executive Assistant to join our team on a 6-month contract. The successful candidate will play a key role in supporting day-to-day CEO operations, with a strong focus on calendar management, event coordination, and general office support. This is a dynamic and highly visible role where you'll be a key partner to executives, ensuring seamless day-to-day operations and contributing to broader strategic initiatives. Contract Duration: 6-9 Months beginning November 2025. Potential for full-time employment at the end of the contract based on business need. Responsibilities: * Deliver comprehensive administrative assistance to the CEO, including calendar and inbox management, meeting coordination, document creation, and complex domestic and global travel arrangements. * Serve as a liaison between the CEO and executive leadership team, ensuring alignment and streamlined communication. * Manage the CEO's professional and personal calendar and provide event support, liaising with family members as needed. * Filter and prioritize incoming requests, communications, and documents for the CEO with the utmost discretion. * Plan and execute internal and external meetings, leadership offsites, and industry events, including communications, logistical components and vendor coordination. * Serve as a primary point of contact for internal and external stakeholders, ensuring timely and professional responses. * Develop agendas for key meetings, capture meeting notes, ensure distribution and follow-through on action items. * Handle ad-hoc administrative tasks and other duties as assigned. * Flexibility to be on site in Brooklyn, based on businesses needs and the schedule of the CEO.

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. Learn more about the company at ***************** Next summer, Cresilon is looking to bring on interns from diverse fields in order for them to gain exposure into the industry. There will be technical and non-technical internships available, which will focus on a specific project. Candidates will be exposed to all aspects of the industry regardless of their placement. The internship is a 10-week onsite program beginning on 1 June 2026. Compensation will be fixed at $30.00/hour for 40 hours/week. Part time opportunities are also available. The application period closes on 27 February 2026. There are ten internship categories available. Please indicate your Top 2 choices in your attached cover letter: 1. Manufacturing Operations and Supply Chain : Interns will assist with supply chain optimization, production planning, supply planning, demand planning, logistics, optimization of processes / process flows, creation and revision of Standard Operating Procedures (SOPs) and batch records, and equipment installation and qualification. Opportunities for compensated travel to conferences and other industry related events exist. 2. Quality Assurance : Interns will assist in establishing the Quality Management System, which serves as the backbone of all quality and regulatory requirements at Cresilon. Interns will help in maintaining the central document control system, implementing OSHA requirements, participating in inspections and reporting any non-conformances. Opportunities for compensated travel to conferences and other industry related events exist. 3. Quality Operations & Compliance : The intern will provide support to the Quality Operations and Compliance department in maintaining and improving the Quality Management System (QMS). This position will offer valuable exposure to ISO 13485 and FDA 21 CFR 820 requirements while assisting in day-to-day compliance activities. The intern's contribution will improve documentation practices, streamline review processes, and boost departmental efficiency while providing them with hands-on support. Opportunities for compensated travel to conferences and other industry related events exist. 4. R&D Formulation : Interns will assist with conducting routine research and development on the subject of polymer formulation development, physical and chemical characterization of polymer materials, structure-property performance in-vivo and process scale-up. Interns will write up and present findings. Opportunities for compensated travel to conferences and other industry related events exist. 5. R&D Process Development : Interns will assist with process development, equipment installation and qualification, creation and revision of Standard Operating Procedures (SOPs), fixture design, and process scale-up. Opportunities for compensated travel to conferences and other industry related events exist. 6. R&D Product Development : Interns will assist with conducting routine research and development on the subject of designing, testing, and improving delivery devices for Cresilon's suite of products. Interns will write up and present findings. Opportunities for compensated travel to conferences and other industry related events exist. 7. Quality Control (Microbiology/Chemistry) : Interns will assist with verifying conformance to in-process specifications and proposing and implementing QC assays. This program will involve working with aseptic technique and interfacing with the manufacturing team. Opportunities for compensated travel to conferences and other industry related events exist. 8. Data Analytics : Interns will assist with identifying new/existing data sources, consolidating and merging redundant datasets, creating and populating databases, designing and automating data entry and data reporting functions, and building extensive data analytics dashboards for continuous monitoring of the company's quality and manufacturing processes. Opportunities for compensated travel to conferences and other industry related events exists. 9. Regulatory Affairs : The Regulatory Affairs Intern will support Cresilon's Regulatory Affairs team in advancing global compliance and market access for its medical device products. This internship provides a hands-on learning experience, with a primary focus on Regulatory Intelligence and global strategic research across multiple markets. 10. Quality Engineering Job Description: Interns will assist with product realization efforts, including design verification & validation, execute software validation activities, including specifications and qualification protocols. This position will provide hands on experience with conducting quality risk assessments as well as authoring risk documents.

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. Learn more about the company at ***************** Description: 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

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. Learn more about the company at ***************** The R&D Formulation Manager/Principal Scientist will lead the design, development, and implementation of novel formulations and polymer materials for use in medical devices, ensuring all activities meet quality and regulatory standards. This role involves providing expertise in formulation development, building and optimizing internal capabilities to deliver innovative and efficient solutions, and ensuring alignment with the company's long-term technical vision to create a strong pipeline of customer-focused innovations. Key responsibilities include developing and characterizing formulations, recruiting and onboarding talent, managing technical collaborations with external suppliers and vendors, and integrating formulations into scalable manufacturing processes, whether in-house or through CDMOs. This role operates in a collaborative, cross-functional environment, requiring flexibility, a strong focus on scientific formulation, and a drive to explore new technologies and techniques in pursuit of robust, innovative materials and products. This is a senior technical role overseeing a small team. The R&D Formulation Manager/Principal Scientist is expected to be a subject matter expert in areas including polymer material science, formulation strategies, analytical chemistry, and biomaterial interactions with biological systems. They are responsible for ensuring high standards in research practices. They are responsible for leading the creation of documentation required for regulatory submissions, developing strategies for grants and publications, and securing non-dilutive funding through grant opportunities. They will report to the Vice President Technology. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities * Lead, staff, and manage formulation development teams and their efforts across multiple parallel product development opportunities, to launch new commercially successful products. * Provide sound scientific leadership, monitoring, and coaching through the initiation, planning and execution their team's overall activities. * Create and lead experimentation for exploratory and/or product development research with focus on polymeric materials and their use. * Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures. * Lead material/design/process changes through design control process, with well-documented research/analyses. * Review and author protocols and reports including development studies and design verification/validation activities. * Develop and implement investigations into new technologies and capabilities, partnering with business development, that advance research team and company objectives. * Lead efforts in chemical and mechanical property evaluation to assess the desirability of process or formulation changes. Develop test method capabilities to support R&D (exploratory research, product development) and production test requirements. * Develop unique, proprietary (and ideally patentable) intellectual property that yields competitive advantage. * Lead and participate in voice-of-customer (VOC) labs and influence go-to-market strategies. * Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication. * Work as part of a cross-functional team to develop, verify, and validate product designs through bench, in-vitro, and in-vivo testing and other assessments. * Ensure an effective documentation system is in place and utilized throughout the development process inclusive of R&D lab notebooks, design reviews, test methods, and test reports. * Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions, * Act as research liaison between R&D and Quality Control to define product specifications. * Maintain active dialogue with Manufacturing to ensure successful technology transfer and process development, including the review of research-related documents * Provide guidance and support to commercial teams, support introduction of new technologies with development of presentations, sales tools, formulations and applications data. * Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company. * Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. * Provide other project, product, or leadership support as needed to support Cresilon's business objective.

Job Description 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. Learn more about the company at ***************** The Production Technician I is responsible for the aseptic manufacturing of Cresilon's products for the animal health industry. The Production Technician II will be trained in clean room operations, aseptic techniques, and must demonstrate the ability to successfully pass gowning qualifications. The position involves operating simple and complex processing equipment, routine sanitization of cleanroom facilities, and manual cleaning of equipment. The ideal candidate will have a proven track record of steady progress in a similar manufacturing environment and must possess a willingness to learn all equipment and jobs in the assigned manufacturing and sanitation of clean room facilities as required. Production Technicians are also responsible for the quality of products produced by ensuring compliance with local, State and Federal regulations, including current Good Manufacturing Practices (cGMP). Perform line clearance of assigned production areas as required. Perform equipment set up and disassembly activities. Operate production, assembly and testing equipment, including heat sealers, bar code scanners, weighing scales, tumblers, autoclaves, filling equipment, and packaging equipment. Formulate, fill, and pouch product in accordance with SOPs. Troubleshoot all operating deviations and issues and coordinate with other functions when required. Report both machine and operating deviations to area supervisor or designee. Perform routine, preventative maintenance on equipment. Perform cleaning and disinfection of the manufacturing spaces. Perform cleaning and sterilization of manufacturing equipment. Perform visual inspection of components and/or product in accordance with SOP's and cGMP's. Perform sampling, intermediate, and finished goods packaging as per SOPs. Package and ship raw materials for sterilization. Perform material receiving, staging, material movements, and material replenishment as per SOPs. Transport samples, materials, and equipment between multiple facilities. Complete data entry and generate reports for material inventory movements. Complete and maintain applicable logbooks and batch record paperwork as required and in accordance with GMP and GDP standards. Maintain a clean production environment during shift. Report all actual, near misses and potential accidents for further investigation. Take immediate action to resolve any near miss situations. Assist in investigation of all actual, near misses and potential accidents. Provide information to troubleshoot and take initiative to resolve operational issues independently. Assist in project commissioning and validation activities, as necessary. Prepare samples or prototypes as required for testing, or other evaluations Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process. Complete all required trainings: Read and Understand (TM1), Computer Based Training with Quiz (TM2), Instructor Led (TM3/TM4), and On-the-Job Trainings (TM5). Oversee training of junior employees on production processes as assigned. Ensure proper communication and handling over of shift duties. Support Environmental and Personnel Monitoring (EM/PM) activities as directed. Responsibilities may include other duties as assigned and as required Requirements HS Diploma or Equivalent with 2+ years of relevant manufacturing experience in the pharmaceutical, biotechnology, or medical device industry OR 2 or 4 year degree with 0+ years of relevant experience. Ability to read, understand, and execute written work instructions. Ability to complete documentation accurately. Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals Ability to become gowning qualified to work in a cleanroom environment. Ability to problem solve and achieve business objectives. Ability to adapt training approach. Willingness to be flexible, and open minded to new processes or changes in direction. Team oriented, building relationships with peers and managers in a proactive manner. Excellent verbal and written communication skills. Proficient in Microsoft Office (Word, Excel, Outlook). Must be able to work overtime and/or second shift when needed. Benefits Paid Vacation, Sick, & Holidays Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage Company Paid Life and Short-Term Disability Coverage Work/Life Employee Assistance Program 401(k) & Roth Retirement Savings Plan with company match up to 5% Monthly MetroCard Reimbursement $20-24/hr Cresilon 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. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job Description 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. Learn more about the company at ***************** Description: The Senior Medical Device Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements. They will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards. The person in this position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required. The position has a scientific focus that includes formulation development, product performance characterization, and implementation, including prototype design and fabrication, and data generation through designed experiments. The Senior Medical Device Engineer is expected to aspire for excellence with a bias toward action, willing to roll up their sleeves, get hands-on, and do what's necessary to move projects forward in a fast-paced environment. They are committed to designing and developing products that dominate the marketplace and improve healthcare by partnering with our customers to drive purposeful innovation, resulting in best-in-class products. The Medical Device Engineer will work with a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of product innovation and robustness. Role level is contingent on experience, but this is not an entry level role.. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use. Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety. Lead cross-functional teams to develop new products, address design issues, and maintain existing designs. Apply strong problem-solving skills to find solutions to complex problems. Work independently to plan and schedule own activities necessary to meet project timelines. Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success. Lead the creation of design history file documentation through the new product development process. Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications. Generate technical protocols/reports to support device safety and efficacy. Invent/create concepts and designs and submit invention disclosures. Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses. Author protocols and reports including development studies and design verification/validation activities. Develop and execute test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes. Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures. Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs. Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication. Maintain a laboratory notebook and other technical documentation to required GLP/GMP guidelines. Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions, Provide support to marketing and sales team, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company. Manage part-time staff as a research leader and mentor for ongoing research projects. Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Provide other project or product support as needed in order to support Cresilon's business objective. Responsibilities may include other duties as assigned and as required. Requirements Required Qualifications BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline. A minimum of 5+ years of product development experience is required. A minimum of 4 years of hands-on experience in new product research and development in a cGMP-regulated industry is required (work experience in the Medical Device field is strongly preferred) Adept experimentalist with hands-on experience in product development of medical devices and their safety/efficacy characterization in an R&D environment. Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans. Experience leading complex product development initiatives from concept through product launch/release. Good working knowledge of anatomy and surgical procedures is required. Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite the completion of critical project tasks Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills. Requires strong leadership skills, excellent written and verbal communication and presentation skills. Working knowledge of FDA requirements as per 21 CFR 820, ISO 9001, ISO 13485:2003, and ISO 14971:2007. Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP) Good understanding of statistical tools and validation/verification techniques. Proficiency in the use of Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required. Legal authorization to work in the United States is required. Preferred Qualifications An advanced degree (MS or Ph.D.) is strongly preferred. Hands-on experience in product development with Class II and Class III medical devices. Experience developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs. Experience with IDE and PMA submissions. Six-Sigma green belt or black belt certification Cresilon 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. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits Competitive annual base salary range of $100,000 - $160,000, depending upon job level and qualifications Paid Vacation, Sick, & Holidays Monthly MetroCard Reimbursement 401(k) & Roth Retirement Savings Plan with company match up to 5% Work/Life Employee Assistance Program Company Paid Life and Short-Term Disability Coverage Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

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. Learn more about the company at ***************** Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: * Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols. * Create and execute product/process enhancement, and new product/process development plans. * Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results, * Author protocols and reports including engineering studies and design verification/validation activities. * Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes. * Prepare samples as required for manufacturing, testing, or other evaluations and data analysis. * Participate in voice-of-customer (VOC) labs and other user needs assessments. * Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes. * Support process and product transfers to manufacturing or CDMOs. * Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines. * Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory. * Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions. * Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data. * Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. * Provide other project or product support as needed to support Cresilon's business objectives.

The Quality Assurance Technician is responsible for routine inspection and testing of raw materials and components as well as of final product for Cresilon's products in the Animal and Human Health industries. This position requires a strong attention to detail as the individual will be responsible for identifying deviations in product quality or safety and ensuring compliance with local, state, and federal regulations, including current Good Manufacturing Practices (cGMP). Position is for 2nd shift. Responsibilities: * Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager. * Perform line clearance activities and in-process inspections. * Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below) * Transfer materials between facilities (see lifting requirements below) * Facility 1 of 2: 122 18th Street, Brooklyn, NY 11215 * Facility 2 of 2: 87 35th Street, Suite 603/604/6R, Brooklyn, NY 11232 * Operate testing equipment such as force testers, torque testers, and balances. * Report all deviations in product, components, raw materials, and equipment per their relevant procedures * Perform document control activities, including but not limited to printing logbooks and batch records. * Transcribe data into digital systems for tracking Quality Metrics. * Batch record review & support routine batch disposition

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. Learn more about the company at ***************** Description: The Senior Medical Device Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements. They will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards. The person in this position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required. The position has a scientific focus that includes formulation development, product performance characterization, and implementation, including prototype design and fabrication, and data generation through designed experiments. The Senior Medical Device Engineer is expected to aspire for excellence with a bias toward action, willing to roll up their sleeves, get hands-on, and do what's necessary to move projects forward in a fast-paced environment. They are committed to designing and developing products that dominate the marketplace and improve healthcare by partnering with our customers to drive purposeful innovation, resulting in best-in-class products. The Medical Device Engineer will work with a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of product innovation and robustness. Role level is contingent on experience, but this is not an entry level role.. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities * Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use. * Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety. * Lead cross-functional teams to develop new products, address design issues, and maintain existing designs. * Apply strong problem-solving skills to find solutions to complex problems. * Work independently to plan and schedule own activities necessary to meet project timelines. * Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success. * Lead the creation of design history file documentation through the new product development process. * Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications. * Generate technical protocols/reports to support device safety and efficacy. * Invent/create concepts and designs and submit invention disclosures. * Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses. * Author protocols and reports including development studies and design verification/validation activities. * Develop and execute test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes. * Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures. * Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs. * Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication. * Maintain a laboratory notebook and other technical documentation to required GLP/GMP guidelines. * Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions, * Provide support to marketing and sales team, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data * Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company. * Manage part-time staff as a research leader and mentor for ongoing research projects. * Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. * Provide other project or product support as needed in order to support Cresilon's business objective. * Responsibilities may include other duties as assigned and as required.