Vice President Software

Biolinq Incorporated • San Diego, CA

11h • $225,000 - $300,000 • Onsite

About The Position

Biolinq’s Vice President, Software is the senior software executive accountable for the strategy, architecture, delivery, quality, and security of all company software. The role owns the software portfolio supporting Biolinq’s intradermal biosensing platform, including iOS and Android applications, backend services and cloud infrastructure, data, analytics and AI services, partner integrations, and internal manufacturing and production software. The position calls for expertise in SaaS metrics and digital health operations, aligning engineering with healthcare compliance, high availability, and commercial growth.

Reporting to the Chief Technology Officer, the VP builds and leads a high-performing software organization and partners with Product, Design, Systems, Quality, Regulatory, Clinical, and Operations. The role combines regulated medical-device software development practices with the speed, user experience, and scale expected of consumer health and wearable products. The position is primarily office-based at Biolinq’s San Diego facility, with possible access to laboratory and manufacturing areas, occasional work outside normal business hours, and travel up to 15%.

Requirements

• Bachelor’s degree in Computer Science, Software Engineering, Computer/Electrical Engineering, or a related technical discipline.
• 15+ years of software development experience, including 8+ years of progressive software leadership managing managers and multidisciplinary teams.
• Proven record delivering regulated medical-device software (SaMD and/or SiMD), preferably connected devices or wearables, from development through FDA clearance/authorization and commercial launch.
• Proven 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.
• Strong technical depth in 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 ability to explain technical concepts, risks, and trade-offs to executives, board members, and partners.
• Demonstrated 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 deploying AI/ML capabilities in products.
• Experience with diabetes, CGM, or metabolic health products.
• Similar experience in other med-tech or health-tech areas.
• Experience supporting both prescription and OTC/consumer product lines and integrations 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 company, product, and technology roadmaps.
• Build, lead, and scale software teams across mobile, platform and cloud, data and AI, DevOps, test and verification/validation, and manufacturing software; evolve the organizational model to meet program needs.
• Define and execute global DevOps and CI/CD strategy, supporting rapid delivery and 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 the technology leadership team on software investments, risks, and trade-offs, and support board, investor, and strategic partner discussions as needed.
• Lead development and lifecycle management of iOS and Android medical-device and consumer/wellness applications, delivering intuitive, accessible, reliable user experiences.
• Establish shared mobile architecture and reusable SDK components, and 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; support uptime, monitoring, and incident response.
• Promote responsible use of AI and machine learning, establishing 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 is developed under 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 cybersecurity and data 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 appropriate for a regulated environment, including CI/CD, automated testing, and efficient verification and validation.
• Define and report software KPIs, and adopt modern tools, including AI-assisted development, to increase engineering throughput.
• Partner with Product Management and Design on requirements and user experience; with Systems, Hardware, and Firmware on sensor-to-app integration; with Clinical on study software; and with 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, holidays, 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