Description
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About the Company Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.
Job Purpose The Vice President, Software is Biolinq’s senior software executive and is accountable for the strategy, architecture, delivery, quality, and security of all company software. This leader owns the full software portfolio that brings Biolinq’s intradermal biosensing platform to users: multiple iOS and Android smartphone applications, backend services and cloud infrastructure, data, analytics and AI services, partner integrations, and the internal manufacturing and production software that supports high-volume sensor manufacturing. The ideal candidate brings a sophisticated understanding of SaaS business metrics and a deep operational background in Digital Health, ensuring our engineering strategies directly align with healthcare compliance, high availability, and scalable commercial growth.
The role requires a rare combination of the rigor of regulated medical device software development (design controls, IEC 62304, risk management, and cybersecurity) with the speed, user-experience excellence, and scale of best-in-class consumer health and wearable products. Reporting to the Chief Technology Officer, the VP, Software builds and leads a high-performing software organization, partners closely with Product, Design, Systems, Quality, Regulatory, Clinical, and Operations, and ensures that software is a strategic differentiator as Biolinq scales commercially and expands its continuous multi-analyte sensing platform.
Strategy & Organizational Leadership
- Define and execute the multi-year software strategy, architecture, and roadmap in alignment with Biolinq’s corporate, product, and long-range technology roadmaps.
- Build, lead, and scale the software organization across mobile, platform/cloud, data and AI, DevOps, test/V&V, and manufacturing software; select and evolve the organizational model (functional groups and/or full-stack product teams) to match program needs.
- Define and execute the global DevOps and CI/CD strategy to minimize time-to-market while maintaining a zero-downtime deployment philosophy across web, cloud, and mobile
- Recruit, develop, and retain top software talent and leaders; set clear goals, coach managers, and foster a culture of ownership, accountability, quality, and continuous learning.
- Own the software budget, headcount plan, and vendor and contractor strategy; make sound build vs. buy vs. partner decisions.
- Serve as a key member of the technology leadership team; advise on software investments, risks, and trade-offs, and support board, investor, and strategic partner discussions as needed.
Mobile Applications (iOS & Android)
- Lead the development and lifecycle management of multiple iOS and Android applications, including medical device apps and consumer/wellness apps, delivering intuitive, accessible, and highly reliable user experiences.
- Establish a shared mobile architecture and reusable SDK components (e.g., Bluetooth sensor communication, data handling, alerts and notifications) to accelerate delivery across product lines.
- Ensure robust phone and OS compatibility, app store release management, and timely readiness for new iOS and Android releases; drive measurable app quality metrics such as crash-free rates, ratings, and engagement.
Backend, Cloud, Data & AI
- Own the design, scalability, reliability, and security of backend services and cloud infrastructure (APIs, data pipelines, storage, user and device management) to support commercial-scale growth with appropriate uptime, monitoring, and incident response.
- Champion and drive the responsible use of AI and machine learning technologies across the software engineering organization, establishing clear governance, data privacy, and ethical compliance standards.
- Enable interoperability and partner integrations with third-party health platforms, connected devices, and healthcare ecosystems.
Manufacturing & Operations Software
- Lead development, validation, and support of internal manufacturing software, including test station and calibration software, equipment and instrument interfaces, production data collection, traceability and device history records, and MES/ERP integrations.
Quality, Regulatory & Cybersecurity
- Ensure all software is developed under Biolinq’s Quality Management System and design controls, in compliance with IEC 62304, ISO 14971, IEC 62366-1, IEC 82304-1, and applicable FDA guidance for device software functions.
- Own software deliverables for regulatory submissions, audits, and inspections; partner with Regulatory Affairs on software regulatory strategy, including change management for future software updates.
- Establish and maintain a secure product development framework, including threat modeling, software bill of materials (SBOM), vulnerability management, and postmarket patching, consistent with FDA cybersecurity requirements (FD&C Act Section 524B); ensure compliance with HIPAA, GDPR, and data privacy requirements.
- Lead postmarket software activities, including field issue and complaint investigations, CAPA, and maintenance releases.
Engineering Excellence & Cross-Functional Partnership
- Partner with Software Quality to drive an agile SDLC suited to a regulated environment, with CI/CD, automated testing, and efficient verification and validation that balance speed and compliance.
- Define and report software KPIs (e.g., release velocity, defect escape rate, system uptime, app quality) 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 teams 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.
Requirements
- Bachelor’s degree in Computer Science, Software Engineering, Computer/Electrical Engineering, or a related technical discipline required; advanced degree (MS or MBA) preferred.
- 15+ years of software development experience, including 8+ years of progressive software leadership with responsibility for managing managers and multi-disciplinary teams.
- Proven track 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 track record delivering consumer-grade mobile applications at scale (e.g., consumer electronics, wearables, digital health, or consumer technology) with high user satisfaction.
- Deep understanding of SaaS
- Experience building or scaling a software organization from pre-commercial through commercial growth. Technical & Regulatory Knowledge
- 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 across native iOS (Swift) and Android (Kotlin) development, Bluetooth Low Energy, cloud platforms (e.g., 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.
- Experience with data platforms, analytics, and deploying AI/ML capabilities in products is strongly preferred.
Preferred
- Experience with diabetes, CGM, or metabolic health products.
- Similar experience in other med-tech or health-tech areas would be considered.
- Experience supporting both prescription and OTC/consumer product lines, and integrations with health ecosystems (e.g., Apple Health, Health Connect, HL7/FHIR).
Leadership Attributes
- Strategic thinker and hands-on builder who can set long-term vision while driving disciplined execution.
- Exceptional communication skills and executive presence; able to translate complex technical concepts, risks, and trade-offs for 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 the highest ethical standards.
Working Conditions
- Primarily office-based at Biolinq’s San Diego, CA facility; may require occasional access to laboratory and manufacturing areas, where personal protective equipment and cleanroom gowning are required.
- May be required to work outside normal business hours to support product releases, critical incidents, and cross-time-zone partners.
- Travel up to 15% (domestic and occasional international) to partners, vendors, conferences, and manufacturing sites.
Physical Requirements While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands and fingers; manipulate office equipment, including a personal computer; handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may occasionally lift/or move up to 15 pounds.
BENEFITS
Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO. At Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke- free workplace.
As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency internally and during the recruitment process. The U.S. base salary range reasonably expected to be paid for this role is: $225,000 to $300,000 per year. We may ultimately pay more or less than the posted range. Actual compensation packages are commensurate with experience and based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S. The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans. Biolinq also offers a comprehensive package of benefits including paid time off (vacation, holidays, sick time, parental leave), medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans and any written agreement between the parties. Your recruiter can share more about the total compensation package during the hiring process.
Please note: The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at Careers@biolinq.com
