Overview In this role you drive a pipeline of new diagnostic products and assays to grow our POC primary care offerings and complementary platforms. You will lead electrochemical sensor and instrument development from concept to market, collaborating across R&D, manufacturing, and external partners. You will shape methods, documentation, and regulatory paths while building IP and leading a cross functional team. This is a hands on leadership role at the intersection of chemistry, engineering, and medical devices, with an impact on patient-facing diagnostics.
Responsibilities- Develop electrochemical systems including screen-printed sensors, reagents, and instruments for clinical use
- Lead projects from conception through commercial launch
- Collaborate with cross functional teams to define requirements, milestones, regulatory paths, and budgets
- Design and execute experiments to test sensor, reagent, and instrument systems
- Create transfer documentation and procedures for manufacturing
- Work with IP counsel to capture and secure intellectual property
- Oversee hardware/software requirements, architecture, design, verification, and validation for medical diagnostics devices
- Manage external development vendors for embedded/firmware and application software
- Lead and motivate interdisciplinary teams to achieve project goals
- Communicate project status and risks to executive leadership
- Maintain quality laboratory standards and record-keeping
- Assess development needs and manage department budgets and expenditures
Key requirements- Degree in Chemistry or Engineering; 3+ years leadership experience
- Experience with regulated medical products and FDA IVD regulatory requirements
- Knowledge of electrochemistry and analytical chemistry; familiarity with diagnostic methodologies
- Experience in point-of-care systems is a plus
- Ability to manage budgets and external vendors; travel 10%
- Proven ability to take projects from conception to commercial launch
- Strong communication skills (oral and written) and cross functional collaboration
- Collaborative
- Curiosity and enthusiasm for improvement
- Leadership and people management
- Electrochemistry
- Analytical chemistry
- Screen-printed sensors
