Research Development Process Engineer Jobs in New Rochelle, 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 www.cresilon.com.

The Director of Research & Development will lead a multidisciplinary team of scientists and engineers, focusing on the development of innovative hemostasis medical devices for both animal health and human markets. This role encompasses the full spectrum of fundamental technology, materials, process, product, and device application development, from early-stage concept research and feasibility assessments to product scale-up, launch, and comprehensive product life-cycle management. They will support the identification of new technologies, materials, processes, and product opportunities and drive acceleration opportunities to support a robust portfolio, and ensure the successful launch of all product programs.

The Director of Research & Development will be responsible for building internal capabilities, recruiting and onboarding top talent, and leading cross-functional, interdisciplinary teams. The Director will also execute a strategic, multi-year technical vision to drive a robust pipeline of customer-centric innovations. Success in this role will require demonstrated expertise in high-impact technology program development and flawless execution, supported by strategic business and technology planning. Additionally, the Director will leverage New Product Introduction (NPI) stage-gate processes to ensure efficient and effective product launches. This role reports directly to the Vice President of Technology.

This is a full-time, on-site position, located in Brooklyn, New York.

Responsibilities:

• Lead, staff and manage Cresilon R&D team across multiple parallel product development opportunities, to launch new commercially successful products and processes in the animal health and human markets.
• Provide sound scientific leadership, support and coaching to R&D team through the initiation, planning, execution and monitoring their overall activities.
• Act as a technical thought leader overseeing a discovery/innovation efforts focused on materials and technologies, providing technical expertise and scientific direction to ensure new product development and applicable sustaining engineering projects are completed successfully to the committed schedule, product specifications and budgets established for the projects.
• Play a lead role in technology transfer, scale-up and process characterization & validation by coordinating the transfer and providing technical assistance in the introduction of new products and processes into manufacturing operations.
• Be an SME for short- and long-term growth strategy across sub-departments within R&D, facilitating the efficient use of resources and aligning personal and project goals with company goals.
• Lead and direct exploratory research development to reflect pipeline expansion goals.
• Regularly interface with Vice President of Technology to ensure research operations reflect overall corporate vision/strategy.
• Ensure compliance with all applicable specifications, standard operating procedures (SOPs), and FDA regulations.
• Ensure that all budgets, schedules, and performance requirements are met.
• Collaborate with stakeholders, functional managers, and cross-functional staff to facilitate seamless project execution including conflict resolution and removal of obstacles to execution.
• Develop and implement investigations into new technologies and capabilities that advance research team and company objectives.
• Provide technical assistance for diagnosing design and manufacturing quality problems.
• Guide development and documentation of test plan protocols, standard operating procedures, specifications, and test procedures
• Review and provide functional approval for project and quality system documentation
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
• Perform other related duties and responsibilities, on occasion, as assigned.

• Work as part of a cross-functional team to develop, verify, and validate product designs through bench, in-vitro, and in-vivo testing and 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.
• Attract, retain, and develop top-tier scientific and engineering technical staff including ensuring technical "know-how" within the R&D team is shared and constantly increasing.
• Develop unique, proprietary (and ideally patentable) intellectual property that yields competitive advantage.
• Lead research department review and other team meetings, develop agendas, handle reviews and follow-up on action items
• Improve efficiency and optimization of existing research operation through implementation of stage-gate process infrastructure.
• Administrate and manage Cresilon grant, SBIR and other non-dilutive funding activities.
• Lead the effort to publish research in peer-reviewed journals
• Develop and implement administrative tools to ensure success and ease of communication between research staff.
• Develop test method capabilities to support R&D and production test requirements.
• Validate current and future testing methodologies as a Subject Matter Expert (SME) on experimental design

Requirements

• Bachelor’s degree in Chemical Engineering, Materials Science & Engineering, Mechanical Engineering, Biomedical Engineering, Chemistry, or related discipline.

• 10+ years of direct management experience required, with the ability to attract, assess, hire, develop, and manage engineers, scientists, and technicians, and influence, motivate, and drive technical rigor.
• 10+ years of experience in developing and utilizing polymer materials, chemistries, or other complex materials toward product/application development and their manufacture is required.
• Demonstrated success leading projects from early development through stage-gate milestones, regulatory submission, and commercial launch is required.
• Experience developing and commercializing these products in a highly regulated environment
• Hands-on research experience with materials chemistry, polymers, adhesives, coatings, biomaterials, naturally-derived materials, and other complex systems, including the development of structure-property performance relationships in designing and characterizing these materials
• Demonstrated experience in Project Management and Product Lifecycle Management practices, and the ability to lead multiple projects simultaneously.
• Strong project management skills and change management leadership skills are required.
• Strong problem-solving and analytical skills
• 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.
• Excellent written and verbal communication skills with the ability to influence cross-functional and senior stakeholders
• Track record of cross‑functional and cross-disciplinary collaboration with R&D, Manufacturing, Regulatory, Quality, and Commercial teams in fast-paced environments
• Ability to identify and lead improvement initiatives, coach/train individuals, and stimulate innovation.
• Ability to identify and analyze complex technical problems and implement innovative solutions
• ·Requires strong leadership and organizational skills with a strong attention to detail and multi-tasking skills while simultaneously keeping an 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, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required.
• Travel will be required, up to 20%, both domestic and international.
• Legal authorization to work in the United States.
• Physical Requirements include the ability to get appropriate vaccinations and clearance to work in an OR/surgical environment, wear appropriate Personal Protective Equipment (PPE), be able to sit and stand, perform normal office work for moderate periods, and the ability to speak, listen, and understand verbal and written communication.

Preferred Qualifications

• A Ph.D. in a relevant discipline is strongly preferred.
• Experience leading product device design and development of regulated medical devices and delivery system platforms from initial concept to release-to-market preferred.
• Strong working knowledge of design control of medical and/or combination product and device development.
• ·Strong knowledge of product development lifecycle, risk management and quality systems
• Working knowledge of medical regulatory requirements for Class II and III medical devices (e.g., 21 CFR Part 820), cGLP/cGMP, and related standards (e.g., ISO 13485).
• Experience with combination products or biologic interfaces is preferred
• Strong understanding of cGMP, ICH guidelines
• Demonstrated experience in Project Management and Product Lifecycle Management practices for large-scale projects preferred.
• 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.
• Prior experience implementing continuous improvement in product development and manufacturing practices is preferred.
• 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. 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 $160,000 - $240,000, 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%