Research And Development Engineer, Suru, MA, US

R&D Engineer (Regulatory Submissions)

Job Description

We are seeking an R&D Engineer to join our fast-paced startup team. This role blends hands-on engineering with exposure to regulatory submissions (510(k), EU MDR) and will be a critical bridge between product development and regulatory strategy. The right candidate will come from an engineering background — biomedical, mechanical, or related — and have some experience touching regulatory documentation or submissions. Prior regulatory affairs experience is not required ; instead, we are looking for an engineer eager to learn and grow in regulatory, while being able to collaborate cross-functionally and hold their own in technical discussions with R&D peers.

Day-to-Day

• Partner closely with R&D and design teams to understand technical product details and contribute to regulatory documentation.
• Support preparation of regulatory submissions (e.g., 510(k), EU MDR technical files) by translating engineering data into regulatory language.
• Participate in design reviews, design changes, and risk assessments with a regulatory lens.
• Assist in maintaining compliance with regulatory standards while contributing to ongoing product development.
• Work cross-functionally with engineers, quality, and regulatory staff to anticipate challenges and propose solutions in a startup environment.
• Learn regulatory processes, pathways, and strategies directly through mentorship and hands-on involvement.

Requirements & Qualifications

• Bachelor’s degree in engineering required (biomedical, mechanical, or related discipline strongly preferred).
• 2+ years of experience in product development, biomedical engineering, or R&D within the medical device industry.
• Exposure to regulatory submissions (510(k), EU MDR) through prior projects or collaboration is strongly preferred, but not required.
• Strong technical communication skills — able to clearly articulate engineering concepts across functions.
• Interest in building regulatory expertise while leveraging a strong engineering foundation.
• Startup mindset: adaptable, proactive, and comfortable working across multiple functions.