Nuclein is an Austin-based, private equity funded, medical device company that offers an innovative, FDA EUA authorized, rapid PCR, point-of-care system. The Nuclein® DASH™ Rapid PCR System is easy-to-use, affordable, and provides PCR results in only 15 minutes.
Our vision is to enable simple, affordable, rapid and accurate testing for everyone. We are a dedicated, talented and diverse team of scientists, engineers and experienced professionals who are driven to excel and make a significant contribution to the world. At Nuclein, we offer a fast-paced, exciting, collaborative environment where individual contributions are highly valued as we work to expand the use of our transformative testing technology in the market.
Please visit Nuclein.com for more information about our company's history, technology, and vision.
The Software Product Manager will be responsible for leading and supporting development activities for current and next-generation software, as well as the ongoing support of on-market software solutions. The individual will collaborate closely with cross-functional teams, including engineering, assay development, marketing, customer support, design, clinical experts, and regulatory affairs, to deliver innovative software solutions. The successful candidate will play a pivotal role in shaping the software strategy and roadmap for Nuclein's DASH Rapid PCR System. DASH is a simple, affordable, point-of-care platform that performs sample-to-answer PCR in 15 minutes.
- Lead the software product strategy, defining a clear vision, roadmap, and priorities for DASH.
- Participate in UI, architecture and bug review meetings throughout the course of new product development projects.
- Collaborate with cross-functional teams to gather customer feedback, clinical insights, and market trends to inform software development decisions.
- Develop detailed product requirements and feature specifications that guide the software development process.
- Work closely with software engineers, designers, and UX specialists to ensure the software aligns with user needs.
- Collaborate with regulatory affairs to ensure software products meet regulatory requirements, including FDA regulations and ISO 13485 standards.
- Define and manage the software product lifecycle, from concept to end-of-life, including version releases, updates, and obsolescence planning.
- Support software related customer complaint investigations.
- Stay current with emerging technologies, industry trends, and regulatory standards relevant to medical device software.
Key Technology Experience:
- C and C++ languages
- IAR compiler experience a plus
- Experience with Linux OS a strong plus
- Experience with ARM Cortex M4 (STM32) microcontrollers a plus
- Familiar with electronic schematic diagrams
- Ability to work close-to-the-metal with embedded hardware
- Knowledge of USB, SPI, I2C, CAN protocols
- Experience with step motors a plus
- Bachelor's degree in computer science or a related field.
- At least 5 years as a Software Product Manager, or at least 10 years as a Senior Programmer with management experience.
- Experience developing medical devices is a strong plus.
- Strong understanding of software development processes, regulatory compliance (FDA regulations, ISO 13485), and quality management; ability to operate in an FDA-regulated environment.
- Experience with UX/UI-centered design principles and translating customer needs into software requirements.
- Excellent project management skills, including the ability to prioritize tasks, manage timelines, and drive cross-functional teams.
- Experience managing outsourced / remote teams.
- Strong communication and interpersonal skills; collaborates effectively with diverse teams and stake holders.
- Strategic thinking and practical problem-solving abilities, with a results-oriented approach to product development.
- Demonstrated leadership skills and the ability to influence decision-making at all levels of the organization.