Job Description

Description

Lead the development of next-generation mobile, backend, and cloud-connected solutions for regulated medical devices and digital health products. This role will shape system architecture, review technical deliverables, and ensure that digital health products are secure, scalable, and compliant with regulatory expectations.

Ideally, this candidate will reside near one of our corporate locations: Cleveland, OH; Chapel Hill, NC; Brooklyn Park, MN

RESPONSIBILITIES

Technical Management

1. Partner with internal teams and contract developers to plan, integrate, and deliver mobile, cloud, and device-connected digital solutions.
2. Provide technical guidance to ensure products meet clinical, regulatory, cybersecurity, and business requirements.
3. Manage architectural decisions, enforce lifecycle processes, and ensure consistent, high-quality execution across internal and outsourced contributors.
4. Apply full-stack understanding (mobile, backend, cloud) to steer implementation while leveraging outsourced partners for development depth.

Software Architecture Oversight

1. Lead technical engagements with outsourced engineering teams, ensuring adherence to SPR’s development lifecycle and quality expectations.
2. Drive scalable, modular architecture decisions across mobile apps, backend services, and cloud infrastructure.
3. Ensure clear segregation and documentation of SaMD vs. non-SaMD functionality, including robust data flows and interface definitions.
4. Create, review and approve requirements, design documentation, and technical deliverables across development and maintenance phases.

Mobile, Cloud, and Backend Execution

1. Oversee outsourced development for mobile applications and backend services, ensuring alignment with SPR’s standards and regulatory needs.
2. Partner with contract developers and IT to ensure secure, validated, and scalable cloud environments.
3. Oversee the definition and maintenance of APIs, data models, and backend services supporting mobile workflows.
4. Establish and mature SPR’s CI/CD pipeline and configuration management processes.
5. Ensure post-market cloud monitoring, performance logging, and issue tracking are implemented and reviewed regularly to drive continuous improvement.

Cybersecurity & Privacy

1. Collaborate with cybersecurity and development partners to embed security-by-design and privacy principles into software development.
2. Support risk assessments, threat modeling, and vulnerability testing.
3. Ensure software and processes adhere to relevant standards and SPR’s risk management framework.

Process Maturity & Team Development

1. Strengthen SPR’s digital software development framework, templates, and toolchain.
2. Identify and implement process improvements that enhance efficiency, traceability, and quality across hybrid teams.
3. Manage and mentor internal software engineers on compliant software practices and architecture principles.
4. Foster a culture of collaboration, pragmatic problem solving, and accountability.

Requirements

KNOWLEDGE AND SKILL REQUIREMENTS

Experience, Competencies, Education:

• Bachelor’s or Master’s degree in Software Engineering, Computer Science, or related field.
• 10+ years of experience in full-stack software development or technical leadership for regulated medical devices or digital health products (IEC 62304, ISO 14971, ISO 13485).
• Comprehensive knowledge of medical software device design standards along with global regulations for medical device software design.
• Proven success managing outsourced developers.
• Excellent communication and cross-functional collaboration skills.

Beneficial Skills and Experience:

• Familiarity with privacy and cybersecurity frameworks.
• Prior team-leading or mentorship experience in hybrid vendor/ internal engineering environments.

WORKING CONDITIONS

• Ability to get the job done in a “we-can-do” environment
• Remote or small office environment.
• Travel will be minimal, and when necessary, can usually be well planned in advance