Sr Software Developer R&D

Under general direction, serves as a senior-level software engineering expert and technical leader in the design, development, testing, and maintenance of software systems supporting regulated medical devices and healthcare solutions. This role combines hands-on software development with technical leadership, contributing to architectural decisions, mentoring engineers, and ensuring delivery of high-quality, compliant software.

Works closely with cross-functional teams including Product Management, Quality, Regulatory, Systems Engineering, and Manufacturing to translate clinical, regulatory, and business requirements into robust, scalable software solutions. Operates with significant autonomy, guiding technical direction, mitigating risk, and promoting engineering excellence across the software development lifecycle (SDLC) in compliance with standards such as IEC 62304, ISO 13485, and FDA design controls.

Essential Functions

• Act as a senior technical expert in the design, development, and maintenance of medical device software and associated applications, supporting both internal and external customers.
• Design and implement front-end applications using Angular, ensuring usability, performance, accessibility, and maintainability in regulated and clinical environments.
• Develop and maintain backend services and APIs using C# (.NET), applying secure coding practices, layered architectures, and scalable design patterns.
• Design, optimize, and maintain SQL Server–based databases, including schema design, performance tuning, data integrity, and support for regulatory traceability.
• Participate in and influence software architecture and technical design, independently leading major components or systems and contributing to cross-platform integration strategies.
• Lead or significantly contribute to continuous improvement and maintenance initiatives across the medical device software portfolio.
• Collaborate closely with Quality Assurance, Regulatory, Systems Engineering, and Manufacturing teams to ensure compliance with applicable medical device regulations and lifecycle processes (e.g., IEC 62304, ISO 13485).
• Develop, maintain, and review software documentation, including requirements, design specifications, risk controls, and verification and validation (V&V) evidence.
• Perform and approve code reviews and test validations, enforcing coding standards, quality practices, and regulatory compliance.
• Identify, assess, and mitigate technical, architectural, and project risks throughout the SDLC.
• Use Jira to manage and track software work items, defects, risks, and technical debt, contributing to sprint planning, estimation, and delivery tracking in Agile/Scrum environments.
• Mentor and guide software engineers, fostering best practices, technical growth, and a culture of quality, ownership, and continuous improvement.
• Clearly communicate technical concepts, design decisions, risks, and project status to engineering leadership and stakeholders.

OTHER DUTIES AND RESPONSIBILITIES

• Serve as a technical point of contact for software-related topics in cross-functional, customer-facing, and inter-site collaborations.
• Support investigation and resolution of software defects, customer complaints, and post-market issues, including root-cause analysis and corrective actions.
• Contribute to the evolution of engineering processes, tools, and CI/CD pipelines, improving quality, efficiency, and compliance.
• Participate in technical evaluations of new frameworks, tools, and technologies relevant to medical software development.
• Assist with hiring, onboarding, and development of software engineers to build and sustain high-performing teams.

Minimum qualification requirements

Academic training

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, or a related field. Equivalent education and experience may be considered.

Experience

• 8+ years of professional software development experience, preferably in regulated or safety-critical environments.
• 3+ years in senior or technical leadership roles within the medical device or healthcare technology industry.
• Demonstrated experience delivering mission-critical medical software systems.
• Strong familiarity with global regulatory requirements for medical devices and healthcare software.

Skills

• Strong proficiency in C# and .NET, with deep understanding of object-oriented design and advanced programming principles.
• Extensive experience with Angular and modern front-end development practices.
• Solid experience with SQL Server, including schema design, optimization, and data integrity.
• Experience with Agile/Scrum methodologies and work tracking using Jira.
• Strong understanding of SDLC in regulated environments, including documentation, traceability, and V&V activities.
• Experience with software architecture and design patterns for scalable and maintainable systems.
• Familiarity with CI/CD pipelines, DevOps practices, and automated testing.
• Experience with microservices architectures; containerization (Docker/Kubernetes) is a plus.
• Knowledge of cybersecurity and compliance frameworks (IEC 62304, ISO 13485, FDA) preferred.
• Excellent analytical, problem-solving, and communication skills.
• Ability to lead through influence, mentor engineers, and collaborate effectively across global, cross-functional teams.

Under general direction, serves as a senior-level software engineering expert and technical leader in the design, development, testing, and maintenance of software systems supporting regulated medical devices and healthcare solutions. This role combines hands-on software development with technical leadership, contributing to architectural decisions, mentoring engineers, and ensuring delivery of high-quality, compliant software.

Works closely with cross-functional teams including Product Management, Quality, Regulatory, Systems Engineering, and Manufacturing to translate clinical, regulatory, and business requirements into robust, scalable software solutions. Operates with significant autonomy, guiding technical direction, mitigating risk, and promoting engineering excellence across the software development lifecycle (SDLC) in compliance with standards such as IEC 62304, ISO 13485, and FDA design controls.

Essential Functions

• Act as a senior technical expert in the design, development, and maintenance of medical device software and associated applications, supporting both internal and external customers.
• Design and implement front-end applications using Angular, ensuring usability, performance, accessibility, and maintainability in regulated and clinical environments.
• Develop and maintain backend services and APIs using C# (.NET), applying secure coding practices, layered architectures, and scalable design patterns.
• Design, optimize, and maintain SQL Server–based databases, including schema design, performance tuning, data integrity, and support for regulatory traceability.
• Participate in and influence software architecture and technical design, independently leading major components or systems and contributing to cross-platform integration strategies.
• Lead or significantly contribute to continuous improvement and maintenance initiatives across the medical device software portfolio.
• Collaborate closely with Quality Assurance, Regulatory, Systems Engineering, and Manufacturing teams to ensure compliance with applicable medical device regulations and lifecycle processes (e.g., IEC 62304, ISO 13485).
• Develop, maintain, and review software documentation, including requirements, design specifications, risk controls, and verification and validation (V&V) evidence.
• Perform and approve code reviews and test validations, enforcing coding standards, quality practices, and regulatory compliance.
• Identify, assess, and mitigate technical, architectural, and project risks throughout the SDLC.
• Use Jira to manage and track software work items, defects, risks, and technical debt, contributing to sprint planning, estimation, and delivery tracking in Agile/Scrum environments.
• Mentor and guide software engineers, fostering best practices, technical growth, and a culture of quality, ownership, and continuous improvement.
• Clearly communicate technical concepts, design decisions, risks, and project status to engineering leadership and stakeholders.

OTHER DUTIES AND RESPONSIBILITIES

• Serve as a technical point of contact for software-related topics in cross-functional, customer-facing, and inter-site collaborations.
• Support investigation and resolution of software defects, customer complaints, and post-market issues, including root-cause analysis and corrective actions.
• Contribute to the evolution of engineering processes, tools, and CI/CD pipelines, improving quality, efficiency, and compliance.
• Participate in technical evaluations of new frameworks, tools, and technologies relevant to medical software development.
• Assist with hiring, onboarding, and development of software engineers to build and sustain high-performing teams.

Minimum qualification requirements

Academic training

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, or a related field. Equivalent education and experience may be considered.

Experience

• 8+ years of professional software development experience, preferably in regulated or safety-critical environments.
• 3+ years in senior or technical leadership roles within the medical device or healthcare technology industry.
• Demonstrated experience delivering mission-critical medical software systems.
• Strong familiarity with global regulatory requirements for medical devices and healthcare software.

Skills

• Strong proficiency in C# and .NET, with deep understanding of object-oriented design and advanced programming principles.
• Extensive experience with Angular and modern front-end development practices.
• Solid experience with SQL Server, including schema design, optimization, and data integrity.
• Experience with Agile/Scrum methodologies and work tracking using Jira.
• Strong understanding of SDLC in regulated environments, including documentation, traceability, and V&V activities.
• Experience with software architecture and design patterns for scalable and maintainable systems.
• Familiarity with CI/CD pipelines, DevOps practices, and automated testing.
• Experience with microservices architectures; containerization (Docker/Kubernetes) is a plus.
• Knowledge of cybersecurity and compliance frameworks (IEC 62304, ISO 13485, FDA) preferred.
• Excellent analytical, problem-solving, and communication skills.
• Ability to lead through influence, mentor engineers, and collaborate effectively across global, cross-functional teams.

Under general direction, serves as a senior-level software engineering expert and technical leader in the design, development, testing, and maintenance of software systems supporting regulated medical devices and healthcare solutions. This role combines hands-on software development with technical leadership, contributing to architectural decisions, mentoring engineers, and ensuring delivery of high-quality, compliant software.

Works closely with cross-functional teams including Product Management, Quality, Regulatory, Systems Engineering, and Manufacturing to translate clinical, regulatory, and business requirements into robust, scalable software solutions. Operates with significant autonomy, guiding technical direction, mitigating risk, and promoting engineering excellence across the software development lifecycle (SDLC) in compliance with standards such as IEC 62304, ISO 13485, and FDA design controls.

Essential Functions

• Act as a senior technical expert in the design, development, and maintenance of medical device software and associated applications, supporting both internal and external customers.
• Design and implement front-end applications using Angular, ensuring usability, performance, accessibility, and maintainability in regulated and clinical environments.
• Develop and maintain backend services and APIs using C# (.NET), applying secure coding practices, layered architectures, and scalable design patterns.
• Design, optimize, and maintain SQL Server–based databases, including schema design, performance tuning, data integrity, and support for regulatory traceability.
• Participate in and influence software architecture and technical design, independently leading major components or systems and contributing to cross-platform integration strategies.
• Lead or significantly contribute to continuous improvement and maintenance initiatives across the medical device software portfolio.
• Collaborate closely with Quality Assurance, Regulatory, Systems Engineering, and Manufacturing teams to ensure compliance with applicable medical device regulations and lifecycle processes (e.g., IEC 62304, ISO 13485).
• Develop, maintain, and review software documentation, including requirements, design specifications, risk controls, and verification and validation (V&V) evidence.
• Perform and approve code reviews and test validations, enforcing coding standards, quality practices, and regulatory compliance.
• Identify, assess, and mitigate technical, architectural, and project risks throughout the SDLC.
• Use Jira to manage and track software work items, defects, risks, and technical debt, contributing to sprint planning, estimation, and delivery tracking in Agile/Scrum environments.
• Mentor and guide software engineers, fostering best practices, technical growth, and a culture of quality, ownership, and continuous improvement.
• Clearly communicate technical concepts, design decisions, risks, and project status to engineering leadership and stakeholders.

OTHER DUTIES AND RESPONSIBILITIES

• Serve as a technical point of contact for software-related topics in cross-functional, customer-facing, and inter-site collaborations.
• Support investigation and resolution of software defects, customer complaints, and post-market issues, including root-cause analysis and corrective actions.
• Contribute to the evolution of engineering processes, tools, and CI/CD pipelines, improving quality, efficiency, and compliance.
• Participate in technical evaluations of new frameworks, tools, and technologies relevant to medical software development.
• Assist with hiring, onboarding, and development of software engineers to build and sustain high-performing teams.

Minimum qualification requirements

Academic training

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, or a related field. Equivalent education and experience may be considered.

Experience

• 8+ years of professional software development experience, preferably in regulated or safety-critical environments.
• 3+ years in senior or technical leadership roles within the medical device or healthcare technology industry.
• Demonstrated experience delivering mission-critical medical software systems.
• Strong familiarity with global regulatory requirements for medical devices and healthcare software.

Skills

• Strong proficiency in C# and .NET, with deep understanding of object-oriented design and advanced programming principles.
• Extensive experience with Angular and modern front-end development practices.
• Solid experience with SQL Server, including schema design, optimization, and data integrity.
• Experience with Agile/Scrum methodologies and work tracking using Jira.
• Strong understanding of SDLC in regulated environments, including documentation, traceability, and V&V activities.
• Experience with software architecture and design patterns for scalable and maintainable systems.
• Familiarity with CI/CD pipelines, DevOps practices, and automated testing.
• Experience with microservices architectures; containerization (Docker/Kubernetes) is a plus.
• Knowledge of cybersecurity and compliance frameworks (IEC 62304, ISO 13485, FDA) preferred.
• Excellent analytical, problem-solving, and communication skills.
• Ability to lead through influence, mentor engineers, and collaborate effectively across global, cross-functional teams.