Senior R&D Engineer (Medical Devices, Global Health)

Senior R&D Engineer (Medical Devices, Global Health)

Location:

Medford, MA (in person)

Employment Type:

Full-Time FLSA Status:

Exempt Purpose Senior R&D Engineers play an important role within a small, highly skilled, and mission-driven team dedicated to advancing newborn and child health. Our newborn respiratory systems have made life saving treatments affordable and accessible for patients around the globe. We are excited to be embarking on new R&D projects and are looking for applicants who can oversee the full product development lifecycle of R&D projects—from early concept and prototyping through testing, refinement, and design transfer to manufacturing. The role requires strong interdisciplinary technical expertise to drive projects forward, as well as clear and effective communication skills to balance detail-oriented execution with strategic oversight and mission alignment. Senior R&D Engineers contribute to high-impact work that demands quality, thoughtfulness, and a deep commitment to improving health outcomes in emerging markets. Key Responsibilities and Duties Lead, plan, coordinate, and participate in new product development and product improvement.

That includes:

Collaborate cross-functionally to gather and define user needs for new products Rapid prototyping to develop proof of concept and final designs Design reviews Development of product and manufacturing specifications Risk management assessments and reports in accordance with

ISO 14971

Formative and summative verification and validation testing Design test fixtures/ setups; identify and qualify sensors for testing Design Transfer to contract manufacturers Inspection of samples, supplier identification, and supplier qualification Preparation of design documentation for submission to regulatory bodies Ensure activities follow design controls to meet the requirements of

ISO 13485

Quality Management System and relevant regulatory bodies. Participate in relevant audits to maintain certifications. Required Skills, Qualifications, and Experience Applicants must be authorized to work in the U.S. without needing visa sponsorship Bachelor's degree in Engineering (i.e. Mechanical, Biomedical, Electrical) 5+ years relevant experience in the medical device industry or other highly regulated design and development environment (eg Aerospace); 3+ years experience with advanced degree Proficiency in CAD (preferably Solidworks), including preparation of 2D and 3D drawings Ability to read, interpret, and apply external standards and guidance documents to a project Demonstrated ability to take initiative, work in a small team, follow timelines, and drive forward projects in line with the organizational priorities. Enthusiasm for problem solving, working across disciplines, and being flexible and open minded to unexpected solutions Previous experience bringing a product from early concept stage to design transfer stage Strong technical writing skills for protocols, reports, and procedures Strong communication with technical and non-technical teammates. Able to be detail-oriented and zoom out to discuss the big picture. Preferred Skills, Qualifications, and Experience Knowledge of ISO 13485, particularly design and development Knowledge of

ISO 14971

Knowledge of GD&T Knowledge of plastic part materials, prototyping, production, and processing Experience in electrical engineering and IEC 60601, including previous work with power electronics, PCB design, and embedded systems Experience with acoustics design and noise reduction Experience with engineering analysis including tolerance analysis, stress/fatigue analysis, and computational fluid dynamics Experience with qualifying and maintaining monitoring and measuring equipment Proficiency in statistical methods and design of experiments Travel Requirements This position may require occasional international travel for site visits to manufacturers and suppliers as needed. For example, they may go to India and Kenya once or twice a year.

Compensation and Benefits Salary Range:

$80,000- $90,000 plus benefits

Pay:

$80,000.00 - $90,000.00 per year

Benefits:

Health insurance Paid time off Retirement plan

Education:

Bachelor's (Required) Ability to

Relocate:

Medford, MA 02155: Relocate before starting work (Required)

Work Location:

In person