Director of Software Engineering
Remote or Hybrid
Posted on 9/26/2023
Cambridge, MA, USA • Rochester, NY, USA • Remote in USA
Experience Level
Desired Skills
Quality Assurance (QA)
QA & Testing
Software Engineering
  • Bachelor's degree in Computer Science, Engineering, or a related field; a Master's degree or higher a plus
  • Minimum of 10+ years of experience in software engineering, with at least 3 years in a leadership role
  • Demonstrated ability to lead and inspire a team
  • Prior experience in a regulated space is required. Experience in the medical device industry, specifically with Class 2 Medical Devices is preferred
  • Strong familiarity or ability to quickly learn regulatory standards, including FDA Guidance, ISO 13485, and IEC 62304
  • Familiarity with Embedded Software Development and concepts. Knowledge of C/C++ preferred
  • Expert knowledge of Cloud Software Development and concepts
  • Hands-on experience with end-to-end medical software products (embedded and/or cloud products with an IoT component preferred
  • Demonstrated ability to establish and follow FDA compliant procedures and processes preferred
  • Work with cross-functional partners and the leadership team to establish objectives and execute on all major product development initiatives which involve software (cloud and firmware)
  • In partnership with the CTO and cross-functional partners, establish Software Development plans and schedules ensuring alignment with the company's strategic objectives and regulatory requirements
  • Direct and oversee the software engineering function for cloud and firmware, including managing the software engineering sprint cycles
  • Lead, mentor, and grow a team of talented software engineers, promoting a culture of rapid innovation, continuous improvement and regulatory compliance
  • Ensure software design, development, validation, and maintenance activities are compliant with FDA Guidance, ISO 13485, IEC 62304, and other relevant regulations and standards
  • Be the liaison to and collaborate with cross-functional teams (e.g., hardware engineering, QA, regulatory affairs, clinical affairs and product management) to ensure seamless product development
  • Manage and oversee the preparation of regulatory documentation pertaining to the software components of FDA submissions
  • Champion the adoption of best practices, emerging technologies, and innovative solutions to ensure product excellence and competitive advantage
  • Identify potential risks in software design and implementation and establish mitigation strategies
  • Other responsibilities as needed