Director of Research & Development
$190000 to $210000 Per Year
Director of Research and Development
A medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal and human health industries that aim to solve problems associated with wound healing.
- 10+ yrs. exp. with plastics and polymers (required)
- R&D experience in the medical device industry
- Deep understanding of materials & handling
- Strategic and Tactical in their work
- Mechanical in nature
- Experience with vaccines and pharmaceuticals preferred
- Operates with a questioning mindset, bringing problems along with multiple solutions to the table.
- Great attitude and work ethic is key
The Director of Research & Development will lead an interdisciplinary team of scientists and engineers with focus in developing novel hemostasis medical devices for the animal health and human markets. His/her efforts span technology, process and product development including material development & characterization, device application development from early concept research, to feasibility assessment, product/process scale-up and all other activities through launch, including all aspects of product life-cycle management. The Director of Research & Development will be responsible for developing internal capabilities, recruiting and onboarding talent, overseeing multi-disciplinary, cross-functional teams and executing a strategic multiyear technical vision to develop a strong pipe-line of meaningful and customer-focused innovation. It is expected that the Director of Research & Development demonstrates high impact technology program development and execution expertise through integrated business and technology strategic planning, leveraging New Product Introduction stage-gate processes. This role reports directly to the Vice President of Technology.
- Lead, staff and manage 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 company 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.
- Bachelor’s degree in Chemistry, Material Science, Chemical Engineering, or closely equivalent discipline is required.
- Ph.D.. in relevant discipline strongly preferred.
- A minimum of 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 is required.
- A minimum of 10 years research experience in developing and utilizing polymeric materials, biomaterials or other complex materials toward product/application development and their manufacture, preference given to medical device experience.
- 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 characterization these materials is strongly preferred.
- Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements along with the 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 required.
- Direct experience in new product development from concept to regulatory approval through launch is required, with strong preference for medical devices.
- Experience developing and commercializing products in a highly regulated environment and sound understanding of medical device regulatory requirements for Class II and III medical devices is strongly preferred.
- Strong knowledge of medical device regulations (e.g., 21 CFR Part 820), cGLP/GMP, and related standards (e.g., ISO 13485) is 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.
- Excellent verbal and written communication skills and 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.
- Ability to identify and analyze complex technical problems and implement innovative solutions is required.
- Demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resource 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 is required.
- Demonstrated experience in Project Management and Product Lifecycle Management practices for large scale projects preferred.
- Strong working knowledge of Microsoft Office is required.
- Legal authorization to work in the United States is required and not requiring future sponsorship for employment visa status (e.g. H1-B status) now or in the future is required.
- Medical, Dental, and Vision Insurance
- Paid Vacation and Holidays
- Firm Paid Life and Short-Term Disability Coverage
- 401(k) Retirement Savings Plan
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