Senior Clinical Development Scientist (Ultras

Job Description

Job Description

???? Location: Bothell, WA • Cambridge, MA • Plymouth, MN (Hybrid – 3 days onsite)

Are you a clinical science expert ready to impact the future of ultrasound technology? Join our innovative team as a Senior Clinical Development Scientist and lead the strategy, execution, and documentation of clinical studies that drive regulatory success and patient outcomes.

???? Key Responsibilities:

• Design and lead clinical studies (pre-market and post-market) for ultrasound products.

• Develop protocols, CSRs, CERs, and regulatory documentation to support FDA and international submissions.

• Collaborate with cross-functional teams (R&D, Regulatory, Medical Affairs, Market Access).

• Engage with investigators, IRBs, and global regulatory agencies (FDA, EMA, NMPA).

• Analyze clinical data, support health economics evidence, and drive publication strategy.

???? Ideal Candidate Has:

• PhD or MD in a relevant scientific field (required).

• 7+ years in clinical research or development, preferably with medical devices.

• Strong experience designing clinical studies for regulatory environments (FDA, EU-MDR).

• Solid understanding of GCP, design controls, and product development processes.

• Excellent writing and communication skills in English for scientific documentation.

• Experience with ultrasound and/or AI-driven clinical validation (a plus).

• Based near one of the required offices with ability to work onsite 3 days/week.

???? Why Join Us?

• Help shape the next generation of ultrasound innovation.

• Collaborate with thought leaders and make an impact globally.

• Competitive salary, benefits, and opportunities for growth.