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Director of Research and Development
17 hours ago
Job Title
Director of Research and Development
Division/Department
Device R&D
Location
Somerville, MA
Reports to
Chief Technology Officer
Key Relationships
Senior Leadership, Quality/Regulatory, Marketing, Manufacturing, Clinical Affairs, Healthcare Economics
About Podimetrics:
Podimetrics is a virtual care management company dedicated to preventing diabetic amputations, one of the most debilitating and costly complications of diabetes. Podimetrics earns high engagement rates from patients and allows clinicians to achieve unparalleled outcomes – keeping vulnerable patients healthy at home and saving limbs, lives, and money. Founded in 2011 by a physician and engineers from MIT and Harvard, Podimetrics is headquartered in Somerville, MA and has a growing team of passionate and mission-driven individuals devoted to improving the lives of patients with diabetes everywhere.
Core Values:
- People First: We care for our people: team, patients, clinicians & health plans, and stockholders.
- Equity Through Diversity: We commit to fostering an inclusive work environment where ideas come from all people to best meet the diverse needs of those we serve.
- Empathy & Compassion: We seek to understand and take action to improve.
- Respectful Candor: We are direct in communication and work to create an environment where all can share their perspectives without risk of repercussions.
- Active Curiosity: We are deeply curious, always striving to learn more and do better.
- Resourcefulness: We are deliberate in our investment of team and capital, creating opportunity regardless of resources.
- Do the Right Thing: We do the right thing, consistent with our values, even when it is challenging.
- Enjoy the Ride: We are going to have a lot of fun doing it.
The Director of Research and Development will be responsible for developing and launching new devices to expand the Podimetrics patient monitoring portfolio and serve a broader range of patients with Diabetes and related complications. The ideal candidate has broad experience managing teams to research, design, and transfer patient monitoring devices to production, is knowledgeable about FDA-regulated design and development processes, is comfortable in a fast-paced and rapidly growing business, and is passionate about patient care.
This is an on-site position based in the Somerville, MA office. Podimetrics has implemented a COVID-related policy for employee safety and requires all staff based at the office to be fully vaccinated.
The role comes with a strong base salary, bonus, and equity structure.
Responsibilities:
Oversee development of new remote patient monitoring devices to broaden the range of patients served by Podimetrics. Build new device design and development team and develop a culture of accountability and excellence within the team. Collaborate with Sales, Marketing, Clinical Affairs, and Healthcare Economics teams to understand customer needs. Identify opportunities to test, learn, and validate assumptions throughout development processes, leveraging interviews and small-scale experiments to drive development decisions.Execute and document planning, risk analysis, design requirements, detailed mechanical, electrical, and software design to achieve requirements, human factors, V&V, and transfer to manufacturing. Follow FDA-compliant design controls and product development processes. Coordinate with Software to integrate monitoring data into software infrastructure. Team with Regulatory and Clinical Affairs to achieve FDA-clearance to market new products.Develop and coordinate establishment of efficient manufacturing processes for the new product.Support continuous improvement of quality and reliability for the existing SmartMat.Identify, in conjunction with commercial, clinical, and leadership teams, opportunities for new products and lead early technology development to support future growth.Qualifications:
Bachelor of Science Degree in Engineering required, Master's degree preferred5+ years' experience of technical leadership experience developing Class 1 or Class 2 medical devices with mechanical, electrical, and software componentsExperience with FDA GMP, GLP and design controls and compliance to ISO 13485: 2016Experience leading diverse and multidisciplinary teamsCompetencies: The successful candidate will embody the following competencies:
Organization and planning: plans, organizes, schedules, and budgets in an efficient, productive manner. Focuses on key priorities.
Ability to hire and develop excellent people.
Analytical skills: able to structure and process qualitative or quantitative data and draw insightful conclusions from it. Exhibits a probing mind and achieves penetrating insights.
Attention to detail: does not let important details slip through the cracks or derail a project.
Persistence: demonstrates tenacity and willingness to go the distance to accomplish success.
Creativity/Innovation: generates new and innovative approaches to problems.
Communication: speaks and writes clearly and articulately without being overly verbose or talkative. Maintains this standard in all forms of written communication, including email.
Leadership: Uphold the values of the company and motivate others to follow their example in contributing to the shared mission with excellence.
Podimetrics is committed to a diverse and inclusive workplace. We are an equal opportunity employer and do not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
