Senior Program Officer, Diagnostic Devices

Job Posting Organization:
The organization is the largest nonprofit dedicated to combating poverty, disease, and inequity globally. Founded on the principle that all individuals, regardless of their identity or circumstances, deserve the opportunity to lead healthy and productive lives, the foundation emphasizes diversity among its employees to reflect the populations it serves. The organization offers a comprehensive benefits package that includes medical, dental, and vision coverage without premiums, generous paid time off, paid family leave, retirement contributions, regional holidays, and opportunities for employee engagement in various communities. The workplace is committed to fostering an environment conducive to both personal and professional growth.

Job Overview:
In this role as a Senior Program Officer for Diagnostic Devices, you will be instrumental in shaping and managing a portfolio of investments aimed at advancing medical device technologies that enhance disease surveillance and diagnosis for various health conditions, particularly in low- and middle-income countries (LMICs). Your responsibilities will include overseeing existing medical devices such as AI-enabled chest x-rays and ultrasounds, as well as exploring novel technologies and screening tools that can bolster public health responses to prevalent diseases like tuberculosis and anemia. You will work collaboratively with both internal teams and external partners to ensure that these medical devices are effectively designed, tested, and deployed in LMIC settings. Your expertise in medical device development will be crucial in prioritizing clinical use cases, navigating regulatory pathways, and strategizing for market access, all while ensuring that the technologies developed have a tangible impact on patient outcomes in the targeted regions.

Duties and Responsibilities:
Your primary duties will include leading the medical device development strategy by identifying and implementing a portfolio of investments that support innovative medical device technologies relevant to the foundation's health priorities. You will collaborate with internal teams and external experts to integrate these devices into broader global health programs. Additionally, you will consult with grantees and partners to enhance project impacts, develop clear target product profiles, and create well-structured device development plans. You will also be responsible for designing and managing grants and contracts related to medical device research and development, ensuring that projects meet technical, regulatory, and commercial milestones. Establishing and managing partnerships with technology developers, manufacturers, research institutions, and regulatory bodies will be key to your role. You will provide technical mentorship to grantees and apply your expertise in product development to manage grants effectively, utilizing risk-based decision-making methodologies. Furthermore, you will support regulatory engagement for medical devices, develop strategies for accelerating device adoption, and collaborate with data scientists to inform device development and deployment strategies. Your role will also involve representing the foundation at various constituencies, making presentations, attending conferences, and engaging in outreach to gather insights from partners and beneficiaries.

Required Qualifications:
Candidates must possess an advanced degree (PhD, MD, or MSc) in biomedical engineering, mechanical engineering, or a related field. A minimum of 10 years of experience in medical device development is required, encompassing product design, clinical validation, regulatory strategy, commercialization, and product introductions. Experience with diagnostic devices, patient monitoring tools, or therapeutic medical technologies is essential. A solid understanding of regulatory approval processes for medical devices, including familiarity with the FDA, EMA, CDSCO, or WHO prequalification programs, is necessary. Experience with AI regulations is considered a plus. Candidates should have a proven track record of managing multidisciplinary teams and partnerships across research institutions, industry, and global health organizations. The ability to drive projects from concept to commercialization, particularly in low-resource settings, is crucial. Strong program management skills, including grant and contract management, are required, along with exceptional written and oral communication skills for effective stakeholder engagement and advocacy.

Educational Background:
The educational background required for this position includes an advanced degree such as a PhD, MD, or MSc in biomedical engineering, mechanical engineering, or a closely related field. This advanced education is essential to ensure that the candidate possesses the necessary technical knowledge and skills to navigate the complexities of medical device development and implementation in global health contexts.

Experience:
Candidates should have at least 10 years of relevant experience in medical device development, which includes comprehensive knowledge of product design, clinical validation processes, regulatory strategies, and commercialization efforts. Experience specifically related to diagnostic devices, patient monitoring tools, or therapeutic medical technologies is highly valued. The ability to manage multidisciplinary teams and partnerships effectively is also crucial, as is a demonstrated capacity to drive projects from initial concept through to successful commercialization, particularly in low-resource settings.

Languages:
While the job description does not specify mandatory languages, proficiency in English is likely essential given the international scope of the organization and the need for effective communication with global partners. Additional language skills may be beneficial, particularly in languages prevalent in low- and middle-income countries where the foundation operates.

Additional Notes:
This position is based in Seattle, WA, and relocation assistance will be provided. The role requires up to 30% travel to partner sites and LMIC settings. The salary range for this position is between $208,600 to $323,400 USD, with higher ranges for specific locations like Seattle and Washington D.C. New hires typically fall between the minimum and midpoint of the salary range, depending on their skills, experience, and expertise. Employment is contingent upon successful completion of a background check, and the organization is committed to providing accommodations for candidates with disabilities during the application process. The foundation emphasizes diversity, equity, and inclusion in its hiring practices, ensuring equal opportunity for all applicants.