Software Architect

As a Software Architect, you will work directly with clients, product teams, and software engineers to define technical strategies, translate customer needs into scalable solutions, and guide development teams from concept through product release. You’ll play a critical role in helping customers navigate complex technical challenges, balancing innovation, regulatory requirements, and business objectives to deliver safe, effective, and high-quality medical device software.

What You’ll Do

• Define and evolve software architectures for complex embedded medical device systems and connected healthcare technologies.
• Design software solutions that prioritize patient safety, reliability, cybersecurity, scalability, and maintainability.
• Establish technical standards, architectural patterns, and development best practices.
• Guide architectural decisions across the software development lifecycle, from requirements through verification and release.
• Participate in risk assessment activities and ensure software designs appropriately address identified hazards and system risks.
• Work directly with customers to understand their business goals, product vision, technical challenges, and regulatory requirements.
• Translate customer needs into practical software architecture strategies and implementation roadmaps.
• Guide customers through technical tradeoffs, helping them make informed decisions regarding cost, schedule, scope, and risk.
• Manage customer expectations through clear communication, transparency, and proactive issue resolution.
• Serve as a trusted advisor during project planning, estimation, execution, and delivery activities.
• Provide technical leadership and mentorship to software engineers and cross-functional project teams.
• Foster collaboration across software, systems, quality, regulatory, and product stakeholders.
• Lead architecture reviews, design discussions, and technical decision-making processes.
• Support the professional growth of engineers through coaching, knowledge sharing, and technical guidance.
• Help teams navigate complex challenges while maintaining focus on project objectives and customer outcomes.
• Collaborate with product owners, clinical specialists, and stakeholders to define software requirements and solution strategies.
• Contribute to project planning, technical estimation, and proposal development.
• Support business development activities through customer discussions and solution presentations.
• Ensure software designs align with regulatory expectations and industry best practices for medical device development.

We are seeking an experienced Software Architect to lead the design and development of innovative embedded medical device software solutions. This role is ideal for a technical leader who combines deep software architecture expertise with a strong understanding of medical device development, customer partnership, and team leadership., * Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, or a related technical field.

• 8+ years of software engineering experience, including significant experience in software architecture and technical leadership.
• Experience developing software for embedded systems, medical devices, or other regulated products.
• Strong understanding of software architecture patterns, system design principles, and distributed system integration.
• Experience leading technical teams and influencing engineering direction across projects.
• Demonstrated ability to work directly with customers and translate business needs into technical solutions.
• Strong communication and relationship-building skills with both technical and non-technical stakeholders.
• Experience balancing technical decisions with project timelines, risks, and customer expectations., * Experience developing Software in a Medical Device (SiMD) solutions.
• Familiarity with Software as a Medical Device (SaMD) products and connected healthcare platforms.
• Knowledge of FDA design controls, IEC 62304, ISO 14971, cybersecurity requirements, and medical device risk management.
• Experience with UML, C4 modeling, or other architecture documentation methods.
• Experience with Agile development practices and modern software delivery approaches.
• Experience supporting customer-facing technical discussions, proposals, or business development activities.

Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting., Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics. Applicants must be currently authorized to work in the United States on a full-time basis. The company is not able to sponsor visas or provide employment-based immigration sponsorship for this role now or in the future.