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9 дней назад

VP, Medical Device Engineering (Medtech)

340 000 - 380 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
c_level
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
VP, Medical Device Engineering (Medtech): Leading the strategy, R&D organization, and commercialization of regulated consumer medical devices with an accent on design controls, quality systems, regulatory compliance, and cross-functional execution. Focus on developing Class II devices, driving FDA clearances such as 510(k), managing technical and operational risks, and scaling high-performing engineering teams.

Location: Menlo Park, California, United States; on-site

Salary: $340,000–$380,000 per year for US-based candidates, plus potential equity compensation

Company

Hims & Hers is a public health and wellness platform providing personalized access to diagnosis, treatment, and delivery.

What you will do

  • Define and execute the strategic roadmap, budget, and resource allocation for the regulated medical device portfolio.
  • Lead R&D for regulated medical devices from early concept through design transfer and commercialization.
  • Build and scale a high-performing, cross-functional medical device organization.
  • Ensure robust design controls, risk management, usability engineering, quality systems, and regulatory compliance.
  • Partner with Quality, Regulatory Affairs, Clinical, Manufacturing, Supply Chain, and executive leadership on product development, submissions, and production readiness.
  • Establish KPIs, improve development lifecycle, time-to-market, and cost efficiency, and mitigate technical, regulatory, and operational risks.

Requirements

  • Bachelor’s degree in Mechanical Engineering.
  • 15+ years of experience in the medical device industry, including significant experience with Class II devices.
  • Proven leadership experience overseeing R&D teams and product development pipelines.
  • Deep knowledge of FDA regulations, including 21 CFR Part 820, and international standards including ISO 13485 and ISO 14971.
  • Demonstrated success leading products through regulatory clearance, such as 510(k), and commercialization.
  • Experience working closely with Quality and Regulatory functions in a design-controlled environment.

Culture & Benefits

  • Full-time roles include competitive salary and equity compensation.
  • Unlimited PTO, company holidays, and quarterly mental health days.
  • Medical, dental, vision, and parental leave benefits.
  • Employee Stock Purchase Program and 401(k) with employer matching contribution.
  • Offsite team retreats and a culture focused on ethics, wellness, diversity, and belonging.

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