We are seeking a dynamic technical leader to join our team. The Director of Software Engineering will provide strategic guidance and leadership to our cloud and firmware teams, ensuring the seamless development and deployment of cutting-edge Class 2 medical device solutions. We are looking for an individual who possesses a deep technical acumen, and who will roll up their sleeves when the situation demands. The right candidate will have excellent communications skills, strong analytical and problem solving skills and the ability to succeed in a fast paced, multi-functional team.

Reporting to the Chief Technology Officer, (CTO) this role is hybrid or remote, preference for the greater Rochester, NY or Boston, MA areas.

What You’ll Do

• 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.

What You’ll Bring

• 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.

About Casana

Casana is innovating healthcare delivery with a smart toilet seat that enables effortless, integrated, and consistent in-home health monitoring. The Heart Seat™ captures key clinical values, including FDA cleared heart rate, blood oxygenation, and future clinical measurements in development such as blood pressure.

The healthcare system has been searching for this actionable intelligence for decades, and it turns out, we were sitting on a great idea all along.

Compensation

[Annual Base Salary $190,000 to $240,000] Exact compensation may vary based on skills, experience and location. Our compensation consists of base salary and equity as well as a generous benefits package.

Casana provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.