Senior Manager, SaMD ML Engineering & Delivery

Whoop

Boston (MA)

Hybrid

USD 170,000 - 230,000

Full time

14 days+
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Benefits and equity package

Job summary

WHOOP is seeking a Senior Manager, SaMD to lead ML engineers and applied scientists delivering regulated health features. You will set direction, grow leaders, and partner with regulatory, quality, clinical science, product, software, and firmware to ensure clinical-grade outcomes.

Based in Boston, you will balance engineering velocity with rigorous compliance inside FDA/IEC13485 frameworks, build scalable teams, and drive audit readiness while delivering high-impact health solutions.

Qualifications

  • 7+ years in ML, applied science, or software engineering with 3+ years leading teams.
  • Bachelor's degree in CS, Engineering, Applied Math, Biomedical Engineering, or related field.
  • Experience hiring and developing ICs; performance management.
  • Deep familiarity with ML lifecycle: data collection, model training, evaluation, validation, deployment, and monitoring.
  • Direct experience shipping ML-enabled software in regulated environments (FDA, IEC 62304, ISO 13485, ISO 14971).
  • Fluency with regulatory, quality and clinical stakeholders, including V&V, traceability, change control, design history, and audit readiness.
  • Ability to set strategy and prioritize under uncertainty; focus on high-leverage work.
  • Experience building or adopting AI-enabled workflows that improve speed, quality, or decision confidence.

Responsibilities

  • Own delivery, team health, and people outcomes across multiple ML SaMD workstreams.
  • Translate department strategy into clear quarterly plans, milestones, and success criteria; align the team on high-leverage work.
  • Build the team: lead hiring at scale, calibrate the bar for regulated development, onboarding, leveling, growth.
  • Develop the next layer of leadership, coach ICs, manage performance with clarity and care.
  • Set the standard for regulated ML: methodology, validation rigor, and audit readiness.
  • Partner with regulatory, quality, product, software, and firmware leaders to align on roadmap and submission timelines.
  • Own the risk posture for your function; anticipate risks and inform senior leadership.
  • Define and own the operating model for your function; planning cadences, design reviews, data governance, quality gates.
  • Build and raise AI-enabled workflows for development, evaluation, documentation, traceability, and stakeholder communication.
  • Represent the team's work credibly to execs with brevity, evidence, and clarity.

Skills

ML leadership
Regulated development
People leadership
Strategic prioritization
Cross-functional collaboration
Executive communication
AI tooling & workflows
Risk management

Education

Bachelor's degree in CS/Engineering/Applied Math/ Biomedical Eng

Job description

WHOOP is seeking a Senior Manager, SaMD to lead ML engineers and applied scientists delivering regulated health features. You will set direction, grow leaders, and partner with regulatory, quality, clinical science, product, software, and firmware to ensure clinical-grade outcomes.

Based in Boston, you will balance engineering velocity with rigorous compliance inside FDA/IEC13485 frameworks, build scalable teams, and drive audit readiness while delivering high-impact health solutions.

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