Sr. Engineer, Design Quality Assurance

About this role

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, we’re 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 hims.com/about http://hims.com/about and hims.com/how-it-works http://hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals http://www.hims.com/careers-professionals. ABOUT THE ROLE: The Sr. Design Assurance Engineer, reporting to the Director of Device Quality, supports sustaining and new product design and development activities and ensures the effective transfer of new products into manufacturing. We are looking for a strong engineer who enjoys working in a fast paced and rapidly growing environment where taking initiative and collaborating cross-functionally are critical for success.   YOU WILL: - Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. - Acts as an effective team member in supporting quality disciplines, decisions, and practices. - Work within a cross-functional team to identify and implement effective controls for realization of Class II medical devices. - Write various technical documentation for procedure execution, technical rationale, and evidence of the development process. - Support Design Assurance activities as related to Risk Management, Design Controls, and other DA related priorities. - Support Post Market activities, as necessary, of risk based on post-market signals. - Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed. - Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards. - Support the verification, validation, and usability testing to meet or exceed internal and external requirements. - Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints). - Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs). - Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input. - Partner cross-functionally to identify and support value improvement efforts to support business goals. YOU HAVE: - Minimum of a bachelor’s degree in mechanical or biomedical engineering (or other related technical discipline). - 5 - 8+ years of experience in design assurance, new product development or related medical device / regulated industry experience. - Self-motivated with a passion for solving problems and a bias for action. - Strong communication skills (verbal & written). - Demonstrated use of Quality tools/methodologies. - Ability to effectively work and collaborate in a mixed onsite + remote environment. - Demonstrated experience creating detailed technical documents.   PREFERRED QUALIFICATIONS: - Experience in development and/or manufacturing of Class II medical devices - ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis. - Experienced problem solver, capable of facilitating the problem-solving process. - Adaptable and effective collaborator in a team environment or in self-directed work. - Experience with design changes, complaint management, and corrective action.   OUR BENEFITS (THERE ARE MORE BUT HERE ARE SOME HIGHLIGHTS): - 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) - Employee discounts on hims & hers & Apostrophe online products - 401k benefits with employer matching contribution - Offsite team retreats   Conditions of Employment: - This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required. - This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR). - Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs. - Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.   We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect