Research and Development Engineer I/II - Process Development - Cresilon, Inc.

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).   

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 the development and implementation of 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

• Education:  BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline.  An advanced degree (MS or PhD) is preferred.
• Minimum 2 years of previous experience is required for Engineer I and 4+ years experience for Engineer II level.    Lab experience in an industry setting within cGMP-regulated environments is strongly preferred.
• Proficiency as an adept experimentalist with hands-on experience in the process development of polymeric materials and their characterization in an R&D or manufacturing environment. Prior experience developing processes and scaling these up into manufacturing or CDMO is strongly preferred.
• Mechanical/electrical knowledge with the ability to troubleshoot processing equipment is strongly preferred.
• 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.  Six Sigma green belt or black belt certification preferred.
• 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.
• Experience implementing process and quality improvements in a manufacturing environment preferred.
• 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.
• Work experience with the medical device or pharmaceutical industries preferred
• Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:2007 preferred.
• Working knowledge of FDA requirements as per 21 CFR 820 preferred.
• 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.

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