{"id":3883980,"url":"https://alion.io/job/sanofi-hfue-associate-director","title":"HFUE Associate Director","company":{"id":146,"name":"Sanofi","domain":"sanofi.com","url":"https://alion.io/company/sanofi","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":91,"open_postings":101,"ghost_share":0.01,"stale_share":0.297,"repost_share":0.089,"time_to_fill_p50_days":22,"computed_at":"2026-11-09T06:03:00Z"}},"role":"Leadership","role_family":"Leadership","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Morristown, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":148500,"max":214500,"currency":"USD","period":"year","gross":null,"usd_annual":214500},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"Human Factors Engineering","optional":false},{"name":"IEC 62366","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false}],"status":"closed","first_seen_at":"2026-11-06T19:04:13Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-09T09:42:49Z","board_verified":false,"closed_at":"2026-11-09T09:42:49Z","days_open":2,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":2},"description":"Job Title: HFUE Associate Director\nLocation: Morristown, NJ\n\nAbout the Job\nAs a Human Factors & Usability Engineering, Associate Director, you will lead HF/UE strategy and execution across multiple programs and business units, driving user-centric design and ensuring product safety and effectiveness across Sanofi's product portfolio. This role bridges deep technical expertise with strategic leadership - shaping team processes, mentoring HF/UE professionals, and contributing to regulatory strategy and external engagement under the direction of the Director and Global Head of HF/UE.\nThe HFUE, Associate Director, leads human factors and usability engineering activities across a broad portfolio of drug delivery devices and combination products, from early-stage generative research through summative validation and lifecycle management. You will drive cross-functional HF/UE integration, shape team methodologies and tools, and contribute to regulatory strategy and health authority interactions. This role requires both the ability to lead complex programs independently and the strategic mindset to influence organizational direction and develop the next generation of HF/UE talent.\nAbout Sanofi:\nWe deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.\nMain Responsibilities\nLead HF/UE strategy and execution across multiple programs and business units, ensuring rigorous, fit-for-purpose application of human factors engineering from early engagement through LCM\n\nDrive user-centered design processes across the product portfolio, ensuring user needs, use requirements, and UI design decisions are grounded in robust research and risk-based thinking\n\nShape and continuously improve HF/UE processes, methodologies, tools, and templates to advance team capabilities and ensure alignment with current FDA expectations and global standards\n\nLead complex generative, formative, and summative HF/UE studies, including study design, protocol development, execution, data analysis, and reporting\n\nConduct and oversee use-related risk analysis (URRA), task analysis, known use problems analysis, and use-related risk control evaluation across assigned programs\n\nContribute to regulatory strategy and support health authority submissions and interactions\n\nMentor and develop HF/UE team members, providing technical guidance, professional development support, and fostering a culture of excellence and continuous learning\n\nCollaboratecross-functionally with design, regulatory, clinical, quality, and marketing teams as a senior HF/UE leader and strategic partner\n\nEnsure HF/UE compliance and best practices across assigned portfolio, including UEF/DHF deliverables, design controls, and regulatory documentation\n\nManage and oversee external vendors and consultants supporting HF/UE study execution and program delivery\n\nAbout You\nBasic Qualifications\nBachelor's in Engineering, Human factors Psychology, industrial design, Life sciences or related fields.\n\n10+ years of progressive experience in medical device, product human factors engineering, usability engineering,combination product human factors engineering or any related fields.\n\nMastery of all relevant FDA HF Guidance documents, IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, and EMA guidelines\n\nProven ability to lead and manage complex HF/UE programs across multiple concurrent projects with minimal oversight\n\nStrong strategic thinking and demonstrated ability to influence cross-functional teams and drive user-centric outcomes\n\nProven track record of defining and implementing HF/UE processes, methodologies, and best practices within an organization\n\nDeep expertise in generative research methods, formative evaluation techniques, summative validation, and use-related risk analysis\n\nExcellent communication skills (written and spoken English) with demonstrated ability to present complex HF/UE concepts to diverse audiences\n\nWillingness to travel to study sites (up to 20%)\n\nPreferred Qualifications:\nMasters degreein Engineering, Human factors Psychology, industrial design, Life sciences or related fields.\n\nProfessional experience beyond HF/UE spanning design disciplines (user-centric, industrial, IFU, graphic), engineering fields (device, systems, quality), regulatory and risk management, requirements generation, clinical practice, or post-market activities is highly valued, considered a meaningful differentiator, and strengthens cross-functional influence and HF/UE strategy.\n\nExperience leading FDA submissions and regulatory interactions (FDA, EMA, Notified Bodies)\n\nExperience with portfolio-level HF/UE strategy and cross-functional governance\n\nKnowledge of IFU & instructional design for combination products or medical devices\n\nWhy choose us?\nBring the miracles of science to life alongside a supportive, future-focused team.\n\nDiscover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.\n\nEnjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.\n\nTake good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.\n\nShape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.\n\nPower industry-leading performance by leveraging digital, data, and AI-driven innovation - at speed and scale\n\nTransform lives worldwide by delivering life-changing treatments anywhere, anytime.\n\nSanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.\nPursue progress, discover extraordinary\nBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.\nSanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here\nUS and Puerto Rico Residents Only\nSanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.\nNorth America Applicants Only\nThe salary range for this position is:\n$148.500,00 - $214.500,00All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.","description_format":"text","description_chars":8113,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Continuous learning","Parental leave","Professional development","Wellness"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"},{"name":"Puerto Rico","iso":"PR","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Vaccines","Rare Disease Therapeutics","Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-06T19:04:13Z"},{"event":"close","at":"2026-11-09T09:42:49Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 62 · green card filings: 19","filings_12m":62,"filings_prev_12m":85,"green_card_filings_12m":19,"median_offered_wage_usd":127500,"route":null,"cap_exempt":false,"checked_at":"2026-11-09T07:32:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":null,"pay":{"stated_usd_annual":214500,"is_top_pay":false},"html_url":"https://alion.io/job/sanofi-hfue-associate-director","json_url":"https://alion.io/job/sanofi-hfue-associate-director.json","meta":{"generated_at":"2026-11-09T18:37:42Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":3499,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-10T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":146},"rest":"https://alion.io/mcp/rest/get_company?id=146"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsanofi-hfue-associate-director"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fsanofi-hfue-associate-director"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fsanofi-hfue-associate-director"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/sanofi-hfue-associate-director\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsanofi-hfue-associate-director"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3883980}},{"tool":"search_jobs","arguments":{"company":"sanofi.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3883980},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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