{"id":2107379,"url":"https://alion.io/job/edwards-lifesciences-director-systems-engineering-samd","title":"Director, Systems Engineering - SaMD","company":{"id":5220,"name":"Edwards Lifesciences","domain":"edwards.com","url":"https://alion.io/company/edwards","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":51,"ghost_share":0,"stale_share":0.784,"repost_share":0.02,"time_to_fill_p50_days":27,"computed_at":"2026-10-21T05:46:15Z"}},"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":["Irvine, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":159000,"max":226000,"currency":"USD","period":"year","gross":null,"usd_annual":226000},"salary_estimate":null,"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design Controls","optional":false},{"name":"Human Factors Engineering","optional":false},{"name":"IEC 60601","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-08T20:53:59Z","employer_posted_date":"2026-10-08","last_verified_at":"2026-10-21T18:24:03Z","board_verified":true,"closed_at":null,"days_open":13,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":13},"description":"Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.\nInnovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.\nHow you will make an impact:\nEdwards Lifesciences is seeking a highly experienced technical leader to serve as Director, Systems Engineering - SaMD within the Transcatheter Mitral and Tricuspid Therapies (TMTT) organization.\nThis role will serve as the future technical owner of a next-generation software-enabled capital equipment platform and associated digital technologies supporting advanced structural heart therapies.\nThe successful candidate will provide systems leadership, architecture oversight, and technical ownership across the product lifecycle while partnering with geographically distributed engineering teams, OEM suppliers, and cross-functional stakeholders. This individual will influence technical strategy, system design, architecture decisions, product development execution, integration approaches, technical tradeoffs, risk management activities, and overall platform evolution.\nThis is not a traditional people-management role or a process-oriented systems engineering position. It is a Director-level technical leadership role intended for an experienced product builder who has personally developed and commercialized complex capital equipment, Software as a Medical Device (SaMD), or other software-enabled products and can apply that experience to evaluate architecture, technical strategy, resource needs, schedules, risks, and overall program execution.\nThe ideal candidate combines deep technical expertise with strong executive presence and can influence multidisciplinary organizations without direct authority. This role is an individual contributor initially, with the opportunity to build future systems engineering and integration capabilities as technical ownership transitions to Irvine and platform needs evolve.\nKey Responsibilities:\nLead end-to-end integration of a software-enabled capital equipment platform and associated digital technologies, ensuring alignment across hardware, electronics, firmware, software, Software as a Medical Device (SaMD), connectivity solutions, and user interfaces.\nDrive technical execution throughout the product lifecycle by evaluating system requirements, architecture, development plans, verification strategies, schedules, staffing assumptions, and overall program readiness.\nIdentify and resolve system-level issues, integration risks, and execution gaps to support successful product development, commercialization, and long-term product performance.\nServe as the technical leader and systems architecture authority for the platform, guiding system design, architecture development, technical decision-making, and long-term platform evolution while establishing technical ownership within the Irvine organization.\nEnsure architecture, requirements, and design decisions align with user needs, clinical workflows, human factors principles, regulatory expectations, cybersecurity requirements, and long-term business objectives.\nApply systems thinking and Design for Excellence (DFX) principles when evaluating architecture, integration, and product decisions, balancing performance, reliability, quality, manufacturability, serviceability, supply chain considerations, cost, product lifecycle requirements, and commercialization readiness.\nLead knowledge-transfer and ownership-transition activities from geographically distributed development teams while preserving technical knowledge, design intent, and architecture rationale.\nPartner with OEM suppliers, external development organizations, and internal stakeholders to ensure technical alignment, successful execution, and sustainable long-term platform support.\nInfluence technical direction across Engineering, Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, Operations, Program Leadership, and external partners.\nCommunicate technical recommendations, risks, tradeoffs, and program health to engineering teams, functional leaders, and executive leadership while operating as a trusted technical authority who leads through expertise, credibility, collaboration, and sound engineering judgment.\nThis is a fully on-site role based at our corporate headquarters in Irvine, CA.\nWhat you'll need (Required):\nBachelor's Degree in Electrical, Computer, Software, Biomedical, Systems Engineering, or a related technical discipline, with 12 years of experience or equivalent work experience based on Edwards criteria\nSignificant hands-on experience developing and commercializing capital equipment, Software as a Medical Device (SaMD), reusable electronic platforms, digital health technologies, or other complex software-enabled products.\nDeep technical expertise in one or more of the following: software development and architecture; SaMD; embedded systems and firmware; electronics and electrical systems; systems architecture and integration; or digital and connected technologies.\nDemonstrated experience integrating hardware, firmware, software, user interfaces, connectivity solutions, and associated system components into commercial products.\nProven experience serving as a technical lead, systems architect, Chief Engineer, systems engineering leader, or comparable technical authority.\nDemonstrated ability to evaluate technical strategies, architecture decisions, development plans, staffing models, schedules, integration approaches, and program risks based on direct product-development experience.\nDemonstrated experience applying Design for Excellence principles, including Design for Reliability, Design for Manufacturability and Assembly, Design for Testability, and Design for Serviceability.\nDemonstrated systems-thinking capability with experience making complex technical and architectural tradeoffs across software, firmware, electronics, reliability, manufacturability, serviceability, quality, cost, and regulatory requirements.\nExperience applying design controls, requirements management, risk management, and verification and validation practices in a regulated environment.\nWorking knowledge of IEC 60601 and its application to medical electrical equipment development.\nDemonstrated success influencing multidisciplinary and geographically distributed organizations without direct reporting authority.\nStrong written, verbal, presentation, and executive communication skills.\nAbility to travel approximately 10-20%, including domestic and international travel.\nWhat else we look for (Preferred):\nMaster's Degree or equivalent in Electrical, Computer, Software, Biomedical, Systems Engineering, or a related technical discipline, with 10 years of experience \nMedical device development experience, including Class II and/or Class III products.\nSignificant experience developing, commercializing, or supporting SaMD, digital health technologies, connected medical systems, cloud-enabled healthcare platforms, or software-enabled clinical products.\nExperience developing capital equipment platforms used in clinical environments.\nExperience with diagnostic, therapeutic, robotic, imaging, patient-monitoring, or other reusable electronic medical technologies.\nExperience leading architecture and integration activities across software, firmware, electronics, and complex electromechanical systems.\nExperience incorporating clinical needs, human factors principles, and user-centered design methodologies into product development.\nExperience supporting technology transfer, technical ownership transitions, or organizational capability-building initiatives.\nExperience working with geographically distributed engineering organizations and external development or manufacturing partners.\nExperience supporting product lifecycle management, including sustaining engineering, software maintenance, platform evolution, cybersecurity updates, serviceability, and end-of-life planning\nWorking knowledge of IEC 62304, ISO 14971, medical device cybersecurity, human factors engineering, and regulatory submission support.\nAdhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control\nAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.\nFor California, the base pay range for this position is $159,000 - $226,000 (highly experienced). \nThe pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.\nEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.","description_format":"text","description_chars":9736,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Industrial Engineering","Digital Therapeutics","Information Security","Patient Monitoring"],"lifecycle":[{"event":"open","at":"2026-10-08T20:53:59Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 45 · green card filings: 24","filings_12m":45,"filings_prev_12m":77,"green_card_filings_12m":24,"median_offered_wage_usd":125978,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+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":{"score":56,"band":"ok","label":"Likely open","p_open":1,"p_active":0.622,"p_room":0.9,"age_days":12,"expected_fill_days":27,"reasons":["conf:3","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-21T05:46:15Z"},"pay":{"stated_usd_annual":226000,"is_top_pay":false},"html_url":"https://alion.io/job/edwards-lifesciences-director-systems-engineering-samd","json_url":"https://alion.io/job/edwards-lifesciences-director-systems-engineering-samd.json","meta":{"generated_at":"2026-10-21T21:33:25Z","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":30682,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-22T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"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":5220},"rest":"https://alion.io/mcp/rest/get_company?id=5220"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fedwards-lifesciences-director-systems-engineering-samd"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"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%2Fedwards-lifesciences-director-systems-engineering-samd"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"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%2Fedwards-lifesciences-director-systems-engineering-samd"},{"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/edwards-lifesciences-director-systems-engineering-samd\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fedwards-lifesciences-director-systems-engineering-samd"}]}