PATH is currently recruiting for a Senior Product Development Engineer to work in the Medical Devices and Health Technologies Program to advance PATH’s global work to ensure that technologies reach those who need them in developing countries and are optimized for the contexts in which they will be used. The Senior Product Development Engineer will support multiple project teams within the program. Project teams are multidisciplinary and generally include members with technical/scientific, public health, communications, business/commercialization, health economics, and administrative support expertise.

PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide.

The Medical Devices and Health Technologies (MDHT) program at PATH develops, advances, and facilitates commercialization of health technologies for low-resource settings. PATH teams conduct collaborative research and development with universities, manufacturers, and other institutions to develop products that are appropriate and affordable for developing-country use. PATH’s goals in these collaborations are to achieve maximum sustainable public health benefit and to facilitate global technology access.

RESPONSIBILITIES:

• Generate new innovations and design concepts; lead project specific product design development efforts.
• Lead the regulatory functional area for medical devices and be a key member of the Quality Management team for the division.
• Lead the development of global regulatory strategies for products and product categories, interfacing with industry, public health stakeholders (National Regulatory Authorities, ISO, World Health Organization, etc.) and drug/vaccine regulatory counterparts (for combination products).
• Research manufacturing approaches and develop plans for scale-up production.
• Assess and analyze technical innovations and conceptualize product solutions to address unmet health needs. Support development of funding proposals.
• Conduct human factors evaluation/user-acceptability testing.
• Support cost of goods sold (COGS) analyses and the development and implementation of project specific intellectual property and commercialization strategies.

Required Skills Required Experience

• A minimum of 10 years’ experience in medical device product development with in depth knowledge of US Food and Drug Administration Quality Systems regulations and ISO 13485 principles is required.
• An undergraduate or graduate degree in mechanical engineering, manufacturing, engineering, product engineering, industrial design, or chemical engineering is required or an equivalent combination of education and experience.
• Experience assessing manufacturability of medical devices and planning for global regulatory approvals.
• Interdisciplinary project/team leadership experience is preferred.
• Demonstrated success working effectively in a multidisciplinary, international project team and self-directed work environment.
• Experience with CAD (e.g., SolidWorks) solid modeling and production of tolerance engineering drawings.
• Low and Middle Income Country (LMIC) public health, product development, and/or regulatory experience desired.
• Demonstrated technical writing skills (reports, analyses, articles, grant proposals etc.) and verbal communication skills to diverse audiences.
• Experience with connected digital device technologies or drug/device combination products is preferred.
• Experience working on combination products and/or medical devices under design controls is critical. desired.
• Ability to communicate ideas through quick concept sketches is desired.
• Effective working with ambiguity in a strategic learning environment.
• Ability to travel domestically and internationally to support project work.

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PATH is dedicated to building an inclusive workforce where diversity is valued.

PATH is an equal opportunity employer. Every qualified applicant will be considered for employment. PATH does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Education: Required Associates Degree, Preferred Bachelor's Degree Experience: 1-3 years previous experience

This position is eligible for tuition remission at Boston University. Applicants are required to include a resume and cover letter outlining their reason for applying to this position, interest in this position and relevant experience in their application materials.

APPLICANTS WITHOUT BOTH A COVER LETTER & RESUME WILL NOT BE CONSIDERED.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. We are a VEVRAA Federal Contractor.