The Manager, R&D will be responsible for driving creation of a pipeline of new products/assays that will enable company growth within the POC primary care market (Pediatric, OB/Gyn & Family Practice) as well as assays complementary to the lead platform, i.e., other heavy metals.

Tasks/Duties/Responsibilities:

• Research and development of electrochemical systems comprising screen-printed sensors, reagents and instruments, for use in clinical applications. Must have the ability to take a project from conception through to commercial launch.
• Collaborate with other departments, Corporate R&D and consultants/external resources to evaluate potential new project areas, define product requirements, and development milestones, confirm regulatory paths, and set timelines and budgets.
• Devise, establish, and execute suitable experiments in order to develop and test various sensor, reagent, and instrument systems.
• Collaborate to develop methodologies, procedures, protocols, documentation, etc. for transfer of developed products to manufacturing.
• Work with intellectual property counsel to devise and provide documentations for any new intellectual property that results from development work.
• Responsible for developing medical diagnostics devices including hardware and software requirements, architecture, design, implementation, integration, verification and validation planning and testing. Leads a team of interdisciplinary engineers and scientists. Also directs external development vendors for embedded and firmware software development, application software development and specification development.
• Ability to lead a team of scientists: organizing, setting expectations and motivating in order to deliver agreed upon goals.
• Ability to interpret complex data and provide clear recommendations, describing the risks and benefits of different approaches.
• Report regularly to executive team on the status of projects in development, including the ability to succinctly report on accomplishments towards a plan, as well as to evaluate and describe development risks and critical success factors.
• Maintain quality laboratory standards and record keeping.
• Ability to assess product development requirements and work with management to set department budgets. Manage department expenditures.
• Other duties as assigned.

• Degree in Chemistry or Engineering and experience with regulated medical products. Experience in point-of-care systems is a plus.
• Bachelor’s degree with 12 years of practical experience, or Master of Science degree with 9 years of practical experience, or Ph.D. degree with 7 years of practical experience. A minimum of 3 years of leadership experience.
• Knowledge of FDA regulatory requirements for IVD products, including Phase Review process.
• Broad knowledge of electrochemistry and analytical chemistry as well as other diagnostic methodologies.
• Travel: 10%
• Curiosity and enthusiasm – a keen interest in discovering what can be done better/differently, and a positive outlook towards change.
• Focus on accomplishment – possessing a drive to get things done.
• Leadership abilities – demonstrated ability to successfully lead people, teams, and projects, and to get results through others.
• Collaborative – ability to work across teams to accomplish company goals.
• Risk tolerant, someone who is flexible and demonstrates perseverance.
• Broad conceptual judgement, initiative and ability to deal with complex factors and ideas not easily evaluated as well as to make sound decisions when data may be limited.
• Strong oral and written communication skills.