The Founding Lead, Wearables & Biomarker Programs will spearhead two strategic initiatives at Fabulous: launching a Fabulous-branded wearable device through white-label/ODM partners and scaling toward bespoke manufacturing, and establishing a biomarker testing service integrated with the Fabulous platform. This role requires end-to-end ownership of strategy, execution, cross-functional coordination, regulatory compliance, and user experience design to drive product-market fit and long-term scalability.
What You'll Do
- Lead the end-to-end launch of a Fabulous-branded wearable (form factor TBD: ring/band/patch) via white-label/ODM
- Prove product-market fit for the wearable and architect the path to bespoke design and manufacturing
- Own the partner landscape: scout, evaluate, negotiate, and manage ODM/OEMs, component vendors, and fulfillment partners
- Ensure compliance with EU/US regulations for hardware and fulfillment
- Define requirements and roadmap across hardware, firmware, BLE connectivity, app integration, data pipelines, security, and regulatory (CE/FCC; EU MDR classification assessment for wellness vs medical claims)
- Deliver pilot(s) for the wearable, manage QA/RMA, set acceptance criteria, and drive cost/quality at scale
- Stand up a biomarker testing service integrated with Fabulous: panel design, lab partnerships, logistics, reporting, and longitudinal coaching
- Select and contract with accredited labs (EU first; US optional) and a phlebotomy/collection network (in-clinic or at-home kits)
- Integrate biomarker service with LIMS and ensure GDPR/HIPAA-grade data governance
- Define the initial biomarker panel with a clinical doctor, including reference ranges, retest cadence, and action-oriented insights
- Own strategy, roadmap, and execution for both the Wearables and Blood Markers programs
- Build the business case: pricing, COGS, BOM, margins, logistics, and unit economics
- Present make/buy transitions and scale plans
- Ship real things: run pilots (500–2,000 users), then scale
- Define success metrics and run iterative experiments to hit them
- Coordinate cross-functional teams (product, design, data, growth, legal, finance, support)
- Recruit and manage external specialists (HW, firmware, regulatory, quality, clinical advisors)
- Lead regulatory & compliance paths; establish privacy/security controls and consent flows
- Translate raw biosignals and labs into simple, delightful user experiences and coaching loops that drive retention and health outcomes
- Within 30 days: deliver a landscape map with shortlisted ODM/white-label candidates including pros/cons, sample lead times, MOQ, unit economics
- Within 30 days: propose initial biomarker panel, target labs, logistics options, and draft legal/compliance checklist
- Within 30 days: define program KPIs and pilot success criteria
- Within 60 days: have wearable samples in-hand with pass/fail criteria; finalize firmware + app integration plan; prepare pilot protocol
- Within 60 days: secure LOIs/MOUs with labs for biomarkers; draft reports, UI mockups, and LIMS integration spec
- Within 60 days: finalize budgets, timelines, and risk register
- Within 90 days: launch wearable pilot with ≥500 users, including activation/retention dashboards and RMA/QA loop
- Within 90 days: soft launch biomarkers with first cohort (≥200 users) and define retest cadence
- Within 90 days: provide board-level go/no-go recommendations for manufacturing transition and panel expansion
What We're Looking For
- Proven ability to lead end-to-end product launches, particularly in hardware or regulated health tech
- Experience scouting, evaluating, negotiating, and managing ODM/OEMs, component vendors, and fulfillment partners
- Deep understanding of EU/US compliance requirements for hardware (CE/FCC) and wellness/medical devices (EU MDR classification)
- Ability to define technical requirements across hardware, firmware, BLE connectivity, app integration, data pipelines, and security
- Experience managing QA/RMA processes and setting acceptance criteria for hardware products
- Experience building business cases including pricing, COGS, BOM, margins, logistics, and unit economics
- Ability to ship and manage pilot programs with 500–2,000 users
- Proven ability to define success metrics and run iterative experiments
- Experience coordinating cross-functional teams across product, design, data, legal, finance, and support
- Ability to recruit and manage external specialists (hardware, firmware, regulatory, quality, clinical advisors)
- Leadership in regulatory & compliance paths, including establishing privacy/security controls and consent flows
- Ability to translate complex biosignals and lab data into user-friendly experiences and coaching loops
- Ability to deliver within strict 30/60/90-day milestones as defined
Nice to Have
- Experience with white-label or ODM-based wearable launches (ring, band, patch)
- Prior work in bespoke hardware design and manufacturing transitions
- Experience with biomarker or lab testing services (e.g., Function Health-style)
- Existing relationships with accredited labs in the EU (and optionally US)
- Experience with phlebotomy or at-home sample collection logistics
- Familiarity with LIMS integration and data governance under GDPR/HIPAA
- Clinical collaboration experience (e.g., designing panels with doctors)
- Background in wellness or digital health coaching platforms
Technical Stack
- Hardware development (wearables)
- Firmware development
- BLE (Bluetooth Low Energy) connectivity
- App integration (mobile/software)
- Data pipelines
- Security protocols
- LIMS (Laboratory Information Management Systems)
- GDPR compliance tools
- HIPAA compliance tools
- Regulatory frameworks (CE, FCC, EU MDR)
Team & Environment
- Founding role; will build and lead cross-functional teams and external specialists
- Cross-functional leadership role coordinating product, design, data, growth, legal, finance, and support teams
Benefits & Compensation
- Opportunity to submit contractor/consultant proposals for the first 3–6 months if able to move fast and de-risk the path to scale
Fabulous is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
