Manager of Product Development

We are a fast-growing medical device company developing advanced Software as a Medical Device (SaMD) solutions for interventional cardiology and structural heart procedures. Our flagship technology integrates real-time fluoroscopy with pre-procedure 3D CT annotations to provide precise intra-procedural guidance, enhancing safety and clinical outcomes.

Our innovation combines CT preprocessing, fluoroscopy preprocessing, AI-driven detection and tracking, anatomical landmark detection, and personalized DRR-based network training with cutting-edge registration protocols. We operate with a small, highly skilled in-house engineering team, supplemented by specialized contractors across several continents.

Manager of Product Development – CARA Medical

CARA Medical is a deep-tech SaaS innovator in structural heart and electrophysiology that develops cutting-edge software solutions for non-invasive visualization of the cardiac conduction system. We are seeking an experienced Manager of Product Development to lead the execution of our product roadmap for a pure SaaS imaging and navigation platform supporting interventional cardiology and electrophysiology procedures (e.g. Transcatheter Aortic Valve Replacement TAVR and Conduction System Pacing CSP). This is a U.S.-based leadership role reporting directly to the Founder. The ideal candidate will manage a distributed software development team and drive cross-functional coordination to deliver high-quality, transformative products in the medtech space.

Key Responsibilities

• Team Leadership: Lead and mentor a remote/distributed software development team, fostering a culture of innovation, accountability, and effective collaboration.
• Cross-Functional Coordination: Drive collaboration across clinical, regulatory, product design, and algorithm/Machine Learning teams to ensure a cohesive product development process and alignment with user needs.
• Product Roadmap Ownership: Own the product roadmap and lifecycle – translate the company's vision into actionable development plans, prioritize features, allocate resources, and ensure on-time delivery of high-quality software releases.
• End-to-End Development: Oversee the entire product development cycle from requirements gathering and design to implementation, testing, deployment, and field support. Ensure feedback loops with clinicians and users for continuous product improvement and iteration.
• Quality & Compliance: Ensure the team adheres to best practices in software development and quality assurance – including careful planning, design reviews, rigorous testing, and documentation – which are especially critical in a high-stakes, FDA-regulated environment.
• Regulatory Alignment: 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.
• Technical-Clinical Bridge: 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.
• Stakeholder Communication: 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.
  
  

Qualifications & Experience

• Education: Bachelor's degree in Engineering, Computer Science, Biomedical Engineering or a related field (or equivalent experience). An advanced degree or MBA is a plus.
• Industry Experience: 5 years of experience in product development, product management, or software engineering leadership, preferably in medtech or healthcare SaaS (digital health, medical imaging, or similar domains).
• Team Management: Proven ability to manage and mentor software development teams and deliver complex software products. Experience leading remote or distributed teams is highly valued.
• Cross-Functional Skills: 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.
• Product Lifecycle Knowledge: Deep understanding of the product development lifecycle, from initial requirements and design through agile development, testing/QA, deployment, and post-market support/iteration. Demonstrated success in executing product roadmaps and meeting project milestones.
• Regulatory & QMS Familiarity: 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.
• Technical & Clinical Aptitude: 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.
• Healthcare Software Experience: 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.
• Leadership & Communication: Excellent leadership, organizational, and decision-making skills. Able to prioritize effectively, manage risk, and navigate uncertainty. Exceptional communication skills with a collaborative mindset, capable of inspiring teams and building consensus.
• Passion & Mission Alignment: A driven, mission-oriented attitude with a passion for medical innovation. Enthusiasm for improving patient outcomes through technology and comfort working in a fast-paced startup environment.
  
  

Why This Role is Meaningful

• Make a Real Impact: Your work will directly support cardiologists and electrophysiologists in delivering life-saving procedures (such as TAVR and CSP), helping to improve patient outcomes and quality of care.
• Innovate at the Cutting Edge: Lead the development of a state-of-the-art platform that combines advanced imaging, 3D navigation, and machine learning. You'll be pushing the boundaries of what's possible in guiding cardiac interventions and setting new standards in the field.
• Leadership & Growth: Reporting directly to the CEO, you will be a key voice in company strategy and product direction. This high-visibility role offers significant autonomy and the opportunity to shape a product that could transform how structural heart and EP procedures are performed.
• Mission-Driven Culture: Join a passionate, multidisciplinary team dedicated to advancing structural heart and electrophysiology care. CARA Medical's solutions enable personalized cardiac pacing and safer structural heart interventions– our mission is to harness technology to save lives and improve cardiac care.
• Collaborative Environment: You'll work closely with leading clinicians, engineers, data scientists, and regulatory experts. This cross-functional collaboration provides a unique opportunity to broaden your expertise and amplify your impact on a critically important healthcare innovation.
  
  

If you are an experienced product development leader eager to drive a groundbreaking SaaS solution in medtech, we encourage you to apply. Join CARA Medical and help us shape the future of cardiac intervention technology.

We are currently expanding our team. As a start-up, we are fast paced and have a shared goal to succeed in developing unmet healthcare needs in the most efficient way. If you share this vision and are interested in joining us - please apply. We look forward to hearing from you.