What are the responsibilities and job description for the Lead Software Engineer position at ClariMed, Inc.?
About ClariMed:
ClariMed is a human-centered development and regulatory practice for medical products developed by pharmaceutical and medical device manufacturers. Our best-of-breed professional services cultivate innovation while ensuring the safe and effective use of medical products.
Operating out of Chadds Ford, PA with offices in San Jose, Boston, and Cambridge, UK, ClariMed is building a global, boutique professional services practice that provides human-centered design, development, and regulatory services to medical device and pharmaceutical manufacturers. While this role can be based at any of our U.S. locations, we have a strong preference for candidates located in or near Orange County, California (Irvine area). With a grounding in quality by design, creativity, and risk mitigation from concept inception through pilot lot delivery, we intend to reduce time to market, enhance product quality, and convey a compelling risk/benefit positioning for our clients. We will achieve this by intentionally coupling the flexibility of a boutique offering with the breadth of services of a global business, while avoiding the conflicts that come with manufacturing and clinical operations.
About the Role:
We are seeking a Lead Software Engineer with at least 7–10 years of experience to take on a technical leadership and client-facing role in developing innovative medical and connected health solutions.
You’re not just a coder - you’re a systems thinker, team mentor, and trusted advisor who’s comfortable meeting clients, understanding their challenges, and translating them into scalable software solutions. You will be a player-coach who thrives in regulated environments and enjoys shaping product roadmaps, guiding architectural decisions, and mentoring teams.
This is a full-time employee position with competitive compensation and benefits. However, if you are an experienced candidate interested in part-time or contract opportunities, we’d still love to hear from you.
Key Responsibilities:
Technical & Architectural Leadership
- Architect secure, scalable, and compliant medical and digital health software solutions.
- Guide cloud-native architectures using Azure (preferred), microservices, and containerization.
- Collaborate with clients, product managers, and cross-disciplinary teams from concept to delivery.
Client Engagement & Mentorship
- Act as a technical lead in client meetings, translating needs into actionable software strategies.
- Provide technical mentorship, code reviews, and foster best practices across teams.
- Influence product and project direction through strong communication and leadership.
Full-Stack & Cloud Development
- Hands-on development using C#/.NET, Python, React, JavaScript, and Azure cloud services.
- Build RESTful APIs, integrate AI/ML features, and implement CI/CD pipelines.
Mobile Development
- Design and implement cross-platform mobile apps using Flutter, React Native, Swift, or Kotlin.
- Ensure seamless integration between mobile apps, cloud services, and connected devices.
Cybersecurity & Regulatory Compliance
- Ensure compliance with FDA regulations, IEC 62304, and ISO 27001.
- Conduct threat modeling, implement secure coding practices, and support cybersecurity risk management.
What We're Looking For:
Must-Haves
- 7 years of professional software engineering experience, including 2 years in a leadership or mentorship role.
- Proven experience in client-facing roles, especially in regulated or medical industries.
- Deep knowledge of C#, .NET, Python, React, JavaScript, and Azure (or AWS/GCP).
- Strong grasp of IEC 62304, FDA software regulations, and cybersecurity best practices.
- Experience with DevOps, unit testing frameworks, and secure cloud deployments.
Bonus Points For
- Cloud certifications (Azure/AWS/GCP)
- Experience with AI/ML in medical or health tech applications
- Familiarity with IoMT, FHIR, or connected health platforms
- Knowledge of Docker/Kubernetes, serverless, and scalable backend systems
Why Join ClariMed?
- Make a real impact on healthcare and patient lives.
- Help shape the future of AI, cybersecurity, and connected health.
- Collaborate with world-class experts in design, engineering, and regulatory strategy.
- Enjoy a flexible, respectful, and high-autonomy work culture.
