{"id":254088,"url":"https://alion.io/job/hims-hers-sr-process-operations-engineer","title":"Sr. Process & Operations Engineer","company":{"id":6261,"name":"Hims & Hers","domain":"hims.com","url":"https://alion.io/company/hims","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Ashby","truth_index":{"grade":"A","score":88,"open_postings":4,"ghost_share":0,"stale_share":0.5,"repost_share":0,"time_to_fill_p50_days":47,"computed_at":"2026-09-27T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Minnetonka, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":130000,"max":150000,"currency":"USD","period":"year","gross":null,"usd_annual":150000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-08-11T23:20:25Z","employer_posted_date":"2026-08-11","last_verified_at":"2026-09-28T01:31:57Z","board_verified":true,"closed_at":null,"days_open":47,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":47},"description":"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.\nHims & 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 and 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.\nAbout the Role:\nThe Senior Process / Operations Engineer - Regulated Devices is responsible for overseeing contract manufacturing operations for a Class II FDA-regulated medical device used for capillary blood collection from a patient’s upper arm into a collection tube for laboratory diagnostic analysis.\nThis role serves as the primary operational and technical liaison between internal teams and Contract Manufacturing Organizations (CMOs), ensuring manufacturing processes, product quality, and operational performance meet all regulatory, quality, and business requirements. The senior engineer will work cross-functionally with R&D, Quality, Regulatory Affairs, Supply Chain, and external manufacturing partners to support product commercialization, process scalability, validation, and continuous improvement initiatives.\nThe ideal candidate has strong experience in medical device process engineering, supplier/CMO management, and regulated manufacturing environments with a deep understanding of FDA and ISO quality system requirements.\nYou Will:\nContract Manufacturing Oversight\nServe as the primary technical operations lead for external contract manufacturers and critical suppliers\n\nOversee day-to-day manufacturing performance, quality metrics, and operational execution at CMOs\n\nEnsure manufacturing processes consistently meet product specifications, quality standards, and production targets\n\nDrive accountability with manufacturing partners regarding timelines, deviations, CAPAs, and continuous improvement initiatives\n\nProcess Engineering & Manufacturing Support\nDevelop, optimize, and sustain manufacturing processes for Class II medical devices and consumables\n\nPartner with R&D during product development and design transfer activities to ensure manufacturability and scalability\n\nSupport process characterization, validation, and verification activities, including: o IQ/OQ/PQ validation\n\nProcess capability studies\n\nEquipment qualification\n\nManufacturing line readiness\n\nLead root cause investigations and implementation of corrective and preventive actions (CAPAs) related to manufacturing or process issues\n\nMonitor process performance and identify opportunities for yield improvement, cost reduction, and operational efficiency\n\nQuality & Regulatory Compliance\nEnsure all manufacturing activities comply with:\nFDA Quality System Regulations (21 CFR Part 820)\n\nISO 13485\n\nGMP requirements\n\nInternal quality system procedures\n\nCollaborate closely with Quality Assurance to address nonconformances, deviations, change controls, and audit findings\n\nSupport supplier qualification, supplier audits, and ongoing supplier quality management activities\n\nEnsure manufacturing documentation, Device History Records (DHRs), and validation records are complete and compliant\n\nCross-Functional Collaboration\nWork closely with R&D teams to transition new products from development into commercial manufacturing\n\nPartner with Supply Chain and Planning teams to support production schedules, inventory management, and demand planning\n\nSupport Regulatory Affairs with manufacturing-related documentation for regulatory submissions and inspections\n\nCoordinate with Packaging, Sterilization, and Logistics teams to ensure seamless product release and shipment readiness\n\nOperational Excellence\nEstablish and monitor KPIs related to manufacturing quality, throughput, scrap, and supplier performance\n\nDrive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies\n\nSupport implementation of scalable operational processes as the company grows\n\nAssist in risk assessments and mitigation activities related to manufacturing and supply continuity\n\nYou Have:\nBachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, or related field)\n\n8+ years of experience in process engineering, operations engineering, or manufacturing engineering within the medical device or diagnostics industry\n\nExperience supporting Class II FDA-regulated medical devices in a GMP manufacturing environment\n\nDirect experience managing or working closely with Contract Manufacturing Organizations (CMOs)\n\nStrong understanding of:\nDesign controls\n\nProcess validation (IQ/OQ/PQ)\n\nFDA Quality System Regulations (21 CFR Part 820)\n\nISO 13485\n\nCAPA and change control systems\n\nExperience collaborating with Quality, Regulatory, and R&D teams in a regulated environment\n\nOur Benefits (there are more but here are some highlights):\nCompetitive salary & equity compensation for full-time roles\n\nUnlimited PTO, company holidays, and quarterly mental health days\n\nComprehensive health benefits including medical, dental & vision, and parental leave\n\nEmployee Stock Purchase Program (ESPP)\n\nEmployee discounts on hims & hers & Apostrophe online products\n\n401k benefits with employer matching contribution\n\nOffsite team retreats\n\nConditions of Employment: \nThis 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.\n\nThis 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).\n\nPhysical 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.\n\nDue 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.\n\nWe 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 match.\nHims 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.\nIt 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.\nHims & 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.\nTo learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.","description_format":"text","description_chars":8373,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Equity","Parental leave","Unlimited PTO"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Telemedicine & Virtual Care","Pharmacies"],"lifecycle":[{"event":"open","at":"2026-09-05T11:14:34Z"}],"liveness":{"score":57,"band":"ok","label":"Likely open","p_open":1,"p_active":0.758,"p_room":0.75,"age_days":46,"expected_fill_days":47,"reasons":["conf:0","velocity","win:late"],"computed_at":"2026-09-27T05:45:00Z"},"pay":{"stated_usd_annual":150000,"is_top_pay":false},"html_url":"https://alion.io/job/hims-hers-sr-process-operations-engineer","json_url":"https://alion.io/job/hims-hers-sr-process-operations-engineer.json","meta":{"generated_at":"2026-09-28T02:31:24Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":1243,"day_limit":5000,"remaining_today":3757,"minute_limit":60,"resets_at":"2026-09-29T00:00:00Z"}}}