{"id":60620,"url":"https://alion.io/job/edwards-director-software-systems-process-and-delivery","title":"Director, Software Systems, Process and Delivery","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":60,"ghost_share":0,"stale_share":0.767,"repost_share":0.033,"time_to_fill_p50_days":26,"computed_at":"2026-10-16T05:45:00Z"}},"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":["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":"Agile","optional":false},{"name":"CI/CD","optional":false},{"name":"Scrum","optional":false}],"status":"live","first_seen_at":"2026-08-17T00:00:00Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-16T03:49:43Z","board_verified":true,"closed_at":null,"days_open":60,"trust":{"level":"ok","repost_count":1,"flags":[],"days_open":60},"description":"Many structural heart patients experience heart failure with limited treatment options. The Implantable Heart Failure Management (IHFM) team, part of the AI, Product and Platforms organization at Edwards Lifesciences, is focused on addressing these unmet needs through pioneering technology that enables earlier, more targeted therapeutic intervention. Our work helps clinicians deliver better care and supports patients in living longer, healthier lives.\nAs Director, Software Systems, Process & Delivery, you will lead the sub-function responsible for how IHFM’s regulated software and data products are planned, documented, orchestrated, and delivered. Through managers and senior individual contributors, you will own delivery execution, release readiness, process and traceability systems, and design control discipline that keeps products audit-ready and aligned to patient, clinician, quality, and regulatory needs.\nBased in Irvine, California, this role is part of a high-impact medtech innovation hub in Orange County, where you will collaborate in person with cross-functional teams to shape patient-focused technology.\nHow you'll make an impact:\nDrive delivery execution and predictability:\nOwn sprint planning, execution, and delivery across software and data teams, driving clear commitments, predictable outcomes, and fast issue resolution.\n\nManage dependencies, sequencing, and delivery trade-offs across complex initiatives.\n\nOwn release orchestration and readiness:\nLead release orchestration, environment promotion, and go-live readiness across the sub-function.\n\nSet release readiness gates, including design freeze, verification-complete, validation-complete, risk assessments, and post-release monitoring.\n\nPartner with Test and DevSecOps teams to incorporate their evidence and security gates into release readiness decisions.\n\nArchitect scalable process and traceability systems:\nEstablish and continuously improve the end-to-end product development process, from intake through release, so delivery remains consistent, compliant, and efficient.\n\nOwn the SSDLC, traceability model, and engineering tool workflows that enable teams to operate with rigor and clarity.\n\nOwn design control and audit readiness:\nLead design control process discipline across the sub-function, supporting alignment with 21 CFR 820.30, IEC 62304, ISO 13485, and ISO 14971.\n\nEnsure delivery, process, and documentation artifacts are audit-ready and inspection-ready in partnership with Quality and Regulatory teams.\n\nLead and grow the team:\nLead the sub-function, or a major portion of it, through managers and senior individual contributors.\n\nBuild leadership capability across the team through hiring, performance management, coaching, and talent strategy.\n\nDrive metrics and continuous improvement:\nDefine and monitor delivery metrics, including predictability, lead time, and throughput, and use insights to improve execution and outcomes.\n\nWhat you'll need (Required):\nBachelor’s or Master’s degree in a related field, or equivalent work experience based on Edwards criteria.\n\nExperience leading Agile delivery execution across software, data, or technology teams.\n\nExperience with regulated product development, software delivery, platforms, or data systems.\n\nThis is an onsite role based in Irvine, CA. Relocation assistance is not provided, and candidates must reside within a 50-mile radius of Irvine to be considered.\n\nWhat else we look for (Preferred):\n12+ years of progressive experience leading delivery, process, or software programs of increasing complexity, including experience managing managers.\n\nDeep expertise in regulated software processes, SSDLC, traceability, and release readiness.\n\nWorking knowledge of design controls, including 21 CFR 820.30, IEC 62304, ISO 13485, and ISO 14971.\n\nProven ownership of end-to-end software and data delivery across multi-team environments, with a track record of predictable Agile execution.\n\nExperience building scalable delivery and development processes and driving organizational change.\n\nFamiliarity with how test automation, CI/CD, and DevSecOps practices support release readiness, with the ability to partner effectively with those teams.\n\nStrong partnership with Product Management on prioritization, sequencing, and trade-off decisions.\n\nAbility to influence engineering, data, business, and executive stakeholders in a matrixed environment.\n\nCertified Scrum Professional (CSP), Advanced Certified ScrumMaster (A-CSM), PMI-PMP, or similar certification.\n\nSaMD pre-market submission or FDA Case for Quality experience.\n\nData-driven mindset, strong communication and leadership skills, and attention to detail while maintaining focus on delivery outcomes.\n\nAbility to lead meetings with internal and external stakeholders, including vendors and partners, to drive alignment and decisions.\n\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 (CA), the base pay range for this position is $159,000 to $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":5523,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":12,"team_size_min":null,"manages_managers":true,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["Relocation assistance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Cardiovascular Devices","Patient Monitoring"],"lifecycle":[{"event":"open","at":"2026-08-17T00:00:00Z"},{"event":"close","at":"2026-09-22T21:54:22Z"},{"event":"reopen","at":"2026-10-14T20:10:41Z"}],"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":15,"band":"cold","label":"Long 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