VP, Regulated Device Engineering
Job Location:
Minnetonka, MN - USA
Monthly Salary:
Posted on:
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Job Summary
Hims & Hers is the leading health and wellness platform on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable accessible and personal from diagnosis to treatment to delivery. No two people are the same so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions were making better health outcomes easier to achieve.
Hims & Hers is a public company traded on the NYSE under the ticker symbol HIMS. To learn more about the brand and offerings you can visit and . For information on the companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit the Role: The VP Regulated Device Engineering is responsible for the overall leadership strategy and execution of the companys regulated medical device business organization. This role owns end-to-end product development from concept through commercialization ensuring compliance with all FDA and global regulatory requirements while driving innovation quality and operational excellence. This leader will directly oversee Research & Development and have cross-functional influence with Quality Regulatory Affairs Clinical and Manufacturing to ensure successful product development approval and market adoption. Define and execute the strategic roadmap for the regulated devices portfolio aligned with company growth objectives Own budgeting and resource allocation for the regulated devices business unit Partner with executive leadership to identify new product opportunities Build and scale a high-performing cross-functional organization Product Development & R&D Leadership Directly lead R&D developing regulated medical devices from concept through design transfer and commercialization Ensure design control processes are robust compliant and efficiently executed (21 CFR Part 820 ISO 13485) Drive innovation while maintaining disciplined product development processes including risk management (ISO 14971) and usability engineering Quality & Regulatory Oversight Ensure all products meet FDA international regulatory and quality system requirements Partner closely with Quality and Regulatory leaders to support successful submissions (e.g. 510(k) De Novo as applicable) Champion a culture of quality and compliance across the organization Ensure inspection readiness and successful audits (FDA notified bodies etc.) Cross-Functional Leadership Provide indirect leadership and alignment across Clinical Manufacturing and Supply Chain Ensure clinical strategies support regulatory and commercial objectives Collaborate with Manufacturing/Operations to ensure scalable cost-effective and compliant production processes Operational Excellence Establish and monitor KPIs across development quality regulatory and manufacturing readiness Drive continuous improvement in product development lifecycle time-to-market and cost efficiency Identify and mitigate technical regulatory and operational risks Bachelors degree in Mechanical Engineering 15 years of experience in the medical device industry with significant experience in 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 such as ISO 13485 and ISO 14971 Demonstrated success leading products through regulatory clearance (e.g. 510(k)) and commercialization Experience working closely with Quality and Regulatory functions in a design controlled environment Competitive salary & equity compensation for full-time roles Unlimited PTO company holidays and quarterly mental health days Comprehensive health benefits including medical dental & vision and parental leave Employee Stock Purchase Program (ESPP) 401k benefits with employer matching contribution Offsite team retreats We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics wellness and a strong sense of belonging. If youre excited about this role we encourage you to applyeven if youre not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment including applicants with arrest or conviction records in accordance with the San Francisco Fair Chance Ordinance the Los Angeles County Fair Chance Ordinance the California Fair Chance Act and any similar state or local fair chance laws. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability please contact us at and describe the needed accommodation. Your privacy is important to us and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status including disability. Please do not send resumes to this email address. To learn more about how we collect use retain and disclose Personal Information please visit ourGlobal Candidate Privacy Statement. Required Experience: ExecBusiness & Strategic Leadership
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About Company
Hims is a one-stop telehealth service for men's wellness and care, providing treatment options for hair loss, ED & more.
