Research and Development Engineer I / II - Process Development

Job Description

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 www.cresilon.com.

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

Preferred Qualifications

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