CARA Medical is seeking a Manager of Product Development to lead the execution of their product roadmap for a pure SaaS imaging and navigation platform supporting interventional cardiology and electrophysiology procedures. The goal is to deliver high-quality, transformative products in the medtech space, improving patient outcomes and advancing cardiac care.
Requirements
- Experience working in a regulated software environment or knowledge of Software as a Medical Device (SaMD) development processes.
- Familiarity with medical device regulations and quality standards (e.g. FDA 510(k) submission process, ISO 13485 QMS, IEC 62304 software lifecycle) is a strong plus.
- Ability to bridge technical and clinical domains.
- Comfortable discussing advanced software topics (machine learning, medical image processing, 3D imaging/navigation) with engineers, while also understanding clinical workflows and needs in interventional cardiology and electrophysiology.
- Experience with enterprise or hospital-based software systems is highly desirable – for example, working knowledge of PACS (medical imaging systems), surgical navigation platforms, electrophysiology mapping systems, or other clinical decision-support tools.
- Proven ability to manage and mentor software development teams and deliver complex software products.
- Deep understanding of the product development lifecycle, from initial requirements and design through agile development, testing/QA, deployment, and post-market support/iteration.
Responsibilities
- Oversee the entire product development cycle from requirements gathering and design to implementation, testing, deployment, and field support.
- Ensure the team adheres to best practices in software development and quality assurance – including careful planning, design reviews, rigorous testing, and documentation
- Collaborate with regulatory and quality teams to navigate compliance requirements (e.g. FDA 510(k) submissions, ISO 13485 quality management system) and integrate them into the development process.
- Act as a bridge between technical and clinical domains – translate complex technical concepts (such as ML algorithms and image registration techniques) into clinically meaningful product features, and ensure clinical feedback informs technical decisions.
- Translate the company's vision into actionable development plans, prioritize features, allocate resources, and ensure on-time delivery of high-quality software releases.
- Ensure feedback loops with clinicians and users for continuous product improvement and iteration.
- Drive collaboration across clinical, regulatory, product design, and algorithm/Machine Learning teams to ensure a cohesive product development process and alignment with user needs.
Other
- Lead and mentor a remote/distributed software development team, fostering a culture of innovation, accountability, and effective collaboration.
- Provide clear updates and communication to the CEO and other key stakeholders on product development progress, roadblocks, and achievements, ensuring transparency and alignment with company goals.
- Strong cross-functional leadership and communication skills – able to work effectively with engineers, clinicians, regulatory specialists, designers, and other stakeholders, including those without technical backgrounds.
- Excellent leadership, organizational, and decision-making skills.
- A driven, mission-oriented attitude with a passion for medical innovation.
