research and developmentmechanical engineeringquality managementregulatory affairsiso 13485medical devicesiso 1497121 cfr part 820510
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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$340к-380к/год
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По похожим ролям (50) ~ $270к/год
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Крутая вакансия
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Чётко определённая руководящая роль в публичной health-tech компании даёт возможность вести портфель регулируемых устройств от концепции до выхода на рынок и влиять на работу разных команд.
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Зарплата выше рынкаШирокая зона влиянияРасширенный соцпакетРабота в офисе
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Текст:
Hirify AI/Оригинал
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.
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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