Software Product Manager

Our client is a dedicated Austin-based, private equity-funded, medical device company that offers an innovative, FDA EUA-authorized, rapid PCR, point-of-care system. Their product is easy-to-use, affordable, and provides PCR results in only 15 minutes. They have a vision to enable simple, affordable, rapid and accurate testing for everyone. They are an incredibly talented and diverse team of scientists, engineers, and experienced professionals who are driven to excel and make a significant contribution to the world.

As they continue to grow exponentially, they are looking to add a Software Product Manager to the team, who 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 best fit for this role 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. In this position, you will play a pivotal role in shaping the software strategy and roadmap for a Rapid PCR System.

What’s in it for YOU? 

  • They offer a fast-paced, exciting, collaborative environment where individual contributions are highly valued as they work to expand the use of transformative testing technology in the market.
  • A wonderful company culture with great core values and looking for team players who also align with them – Value Everyone, Ownership, Innovation, Collaboration and Excellence Driven! 
  • Very exciting time to work with an awesome leadership team has proven experience commercializing biotech, including expertise in system and assay research and development, regulatory, intellectual property, engineering and manufacturing. 
  • This company is in growth mode and is bound for great things! This is an opportunity for you to help make a significant difference with this delivery to the world! 

What YOU get to DO at this growing company:

  • 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 Requirements:

  • Knowledge of 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.
  • Familiarity 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.

What you NEED to SUCCEED in this challenging role:

  • 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 stakeholders.
  • 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.