DataAnnotation

SUMMARY

• Lead the development and integration of digital solutions as part of SPR’s cutting-edge medical device portfolio.
• Drive product development by ensuring that digital applications, including mobile platforms and cloud environments, seamlessly enhance the functionality and user experience of SPR’s medical devices.
• Oversee the design, development, and validation of digital applications for iOS and Android platforms, ensuring seamless integration with cloud-hosted environments.
• This role requires proven technical expertise in digital applications, mobile app development, cloud infrastructure, and cybersecurity, coupled with managing external developers.

PRIMARY RESPONSIBILITIES

Mobile Application Development:

• Oversee the design and implementation of mobile applications, ensuring they meet user needs and regulatory requirements for medical devices
• Integrate mobile applications with medical devices using wireless communication technologies, such as Bluetooth, to deliver seamless functionality
• Guide the selection and application of development frameworks (native or cross-platform) to optimize product timelines and performance.
• Oversee external contract developers to deliver mobile applications and cloud-based solutions on time and within scope
• Support verification, validation, and usability testing to meet NPD goals and ensure product safety and effectiveness
• Collaborate cross-functionally with Marketing, Information Technology, Engineering, Quality, Regulatory, Clinical, R&D, and Manufacturing teams to support all phases of the product lifecycle, from concept to commercial launch.

Cloud Integration & Infrastructure Management:

• Collaborate with IT personnel to support the development and maintenance of cloud-hosted production environments to support secure and scalable digital solutions
• Collaborate with DevOps teams to establish CI/CD pipelines, automated testing, and real-time monitoring for efficient development workflows

Cybersecurity in Product Development:

• Work with Regulatory and Compliance personnel to ensure all digital products meet FDA, ISO, and other relevant standards (e.g. cybersecurity) for Software as a Medical Device (SaMD) and adhere to relevant data privacy laws, embedding security into the software development lifecycle (DevSecOps)
• Collaborate with security teams and oversee risk assessments, vulnerability scans, and penetration testing to identify potential security threats and mitigate risks.

Contract Development Management:

• Coordinate and manage external contract developers, ensuring alignment with internal NPD processes and milestones
• Drive clear communication and collaboration between internal and external teams to balance project timelines, resources, and quality standards

Project Management & Process Improvement:

• Establish and continuously improve workflows, tools, and best practices to accelerate the development of digital products as part of the NPD process
• Partner with Program Managers to ensure efficient execution of digital programs, overseeing project status, identifying risks, and implementing mitigation strategies to keep development on schedule and within budget.

People Management:

• May manage one or more software engineers.

Assumes other related duties as assigned.

KNOWLEDGE AND SKILL REQUIREMENTS

• Bachelor’s degree in Computer Science, Software Engineering, or a related field; advanced degree preferred.
• 10+ years of experience in mobile application development, with a strong focus on integration of digital solutions into medical devices (or equivalent combination of experience and education).
• Proficiency in native iOS and Android development as well as cross-platform frameworks (e.g. Flutter).
• Hands-on experience with Bluetooth or pipeline wireless communication technologies for device integration.
• Experience in managing cloud-hosted platforms, preferably on Microsoft Azure
• Proven track record of leading cross-functional teams and managing external contract development resources in a new product development environment
• Strong understanding of FDA regulations, ISO standards, and medical device cybersecurity requirements
• Strong skills in project management, risk-assessment, and stakeholder communication
• Advanced knowledge of CI/CD pipelines, Agile methodologies, and DevSecOps practices preferred

WORKING CONDITIONS

• Ability to “get the job done” in a we-can-do environment, allowing for flexible hours, depending upon the project and/or customer needs
• Small office environment (does own documentation and interacts directly with others in virtually all situations)
• Travel will be minimal and can usually be well planned in advance.