Vice President Software

Biolinqorporated • San Diego, CA

5d • $225,000 - $300,000 • Onsite

About The Position

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers relevant to managing clinical conditions, including diabetes. The Vice President, Software is the senior software executive accountable for the strategy, architecture, delivery, quality, and security of the company’s software portfolio. This portfolio includes iOS and Android applications, backend services and cloud infrastructure, data, analytics and AI services, partner integrations, and internal manufacturing and production software.

Reporting to the Chief Technology Officer, the VP builds and leads a high-performing software organization and works closely with Product, Design, Systems, Quality, Regulatory, Clinical, and Operations. The role combines regulated medical device software development with consumer-grade product experience and operational scaling, while aligning software strategy with healthcare compliance, high availability, and commercial growth.

The role is primarily office-based at Biolinq’s San Diego, California facility, with occasional access to laboratory and manufacturing areas. Travel of up to 15% is expected. Work outside normal business hours may be required to support releases, critical incidents, and partners in other time zones.

Requirements

• Bachelor’s degree in Computer Science, Software Engineering, Computer/Electrical Engineering, or a related technical discipline.
• At least 15 years of software development experience, including at least 8 years of progressive software leadership managing managers and multidisciplinary teams.
• Proven track record delivering regulated medical device software (SaMD and/or SiMD), preferably for connected devices or wearables, from development through FDA clearance or authorization and commercial launch.
• Proven track record delivering consumer-grade mobile applications at scale with high user satisfaction.
• Deep understanding of SaaS.
• Experience building or scaling a software organization from pre-commercial through commercial growth.
• Deep working knowledge of IEC 62304, ISO 13485, ISO 14971, 21 CFR Part 820, FDA device software and cybersecurity guidance, and HIPAA/GDPR.
• Technical depth across native iOS (Swift) and Android (Kotlin), Bluetooth Low Energy, cloud platforms such as AWS, Azure, or GCP, microservices and API design, databases, DevOps, and CI/CD.
• Experience with manufacturing and test software, production data systems, and software validation for production and quality systems.
• Strategic thinking and ability to set long-term vision while driving disciplined execution.
• Exceptional communication skills and executive presence, including the ability to explain technical concepts, risks, and trade-offs to executives, board members, and partners.
• Ability to attract, develop, and retain high-caliber talent and build an inclusive, high-performance culture.
• User- and patient-centric mindset, data-driven decision making, sound judgment, and high ethical standards.

Nice To Haves

• Advanced degree (MS or MBA).
• Experience with data platforms, analytics, and deployment of AI/ML capabilities in products.
• Experience with diabetes, CGM, or metabolic health products; experience in other med-tech or health-tech areas may also be considered.
• Experience supporting both prescription and OTC/consumer product lines and integrating with health ecosystems such as Apple Health, Health Connect, or HL7/FHIR.

Responsibilities

• Define and execute the multi-year software strategy, architecture, and roadmap in alignment with corporate, product, and long-range technology plans.
• Build, lead, and scale the software organization across mobile, platform and cloud, data and AI, DevOps, test and verification/validation, and manufacturing software; evolve the organizational model to fit program needs.
• Define and execute global DevOps and CI/CD strategy to reduce time to market while maintaining a zero-downtime deployment philosophy across web, cloud, and mobile.
• Recruit, develop, and retain software talent and leaders; set goals, coach managers, and foster ownership, accountability, quality, and continuous learning.
• Own the software budget, headcount plan, and vendor and contractor strategy; make build-versus-buy-versus-partner decisions.
• Advise technology leadership on software investments, risks, and trade-offs, and support board, investor, and strategic partner discussions as needed.
• Lead development and lifecycle management of multiple iOS and Android applications, including medical device and consumer/wellness apps, with intuitive, accessible, reliable user experiences.
• Establish shared mobile architecture and reusable SDK components, including Bluetooth sensor communication, data handling, alerts, and notifications.
• Ensure phone and operating-system compatibility, app store release management, readiness for new iOS and Android releases, and measurable app quality.
• Own the design, scalability, reliability, and security of backend services and cloud infrastructure, including APIs, data pipelines, storage, and user and device management.
• Champion responsible AI and machine learning use across software engineering, with governance, data privacy, and ethical compliance standards.
• Enable interoperability and integrations with third-party health platforms, connected devices, and healthcare ecosystems.
• Lead development, validation, and support of internal manufacturing software, including test station and calibration software, equipment and instrument interfaces, production data collection, traceability, device history records, and MES/ERP integrations.
• Ensure software development follows Biolinq’s Quality Management System and design controls and complies with applicable standards and FDA guidance.
• Own software deliverables for regulatory submissions, audits, and inspections; partner with Regulatory Affairs on software regulatory strategy and change management for future updates.
• Establish and maintain secure product development practices, including threat modeling, software bills of materials, vulnerability management, and postmarket patching; ensure compliance with applicable cybersecurity and privacy requirements.
• Lead postmarket software activities, including field issue and complaint investigations, CAPA, and maintenance releases.
• Partner with Software Quality to implement an agile SDLC suited to a regulated environment, incorporating CI/CD, automated testing, and efficient verification and validation.
• Define and report software KPIs, such as release velocity, defect escape rate, system uptime, and app quality; adopt modern tools, including AI-assisted development, to improve engineering throughput.
• Partner with Product Management and Design on requirements and user experience; Systems, Hardware, and Firmware on sensor-to-app integration; Clinical on study software; and Commercial and Customer Support on launch and field readiness.
• Perform other duties as assigned.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Health savings account
• Flexible spending account
• Life insurance
• Long-term disability insurance
• 401(k) plan
• Holidays
• Paid time off, including vacation and sick time
• Parental leave
• Annual performance bonus and/or other applicable incentive compensation plans may be included

What This Job Offers

• Job Type: Full-time
• Career Level: Executive