{"id":1289545,"url":"https://alion.io/job/irhythm-technologies-senior-design-quality-engineer","title":"Senior Design Quality Engineer","company":{"id":1901464,"name":"iRhythm Technologies","domain":"irhythmtech.com","url":"https://alion.io/company/irhythmtech","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":83,"open_postings":6,"ghost_share":0,"stale_share":0.667,"repost_share":0,"time_to_fill_p50_days":48,"computed_at":"2026-10-14T06:34:16Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Francisco, United States","United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":115000,"max_usd":217000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":5578},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Cypress","optional":false},{"name":"Jira","optional":false}],"status":"live","first_seen_at":"2026-09-24T00:00:00Z","employer_posted_date":"2026-09-24","last_verified_at":"2026-10-14T22:22:41Z","board_verified":true,"closed_at":null,"days_open":21,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":21},"description":"Career-defining. Life-changing.\nAt iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career\nAbout This Role:\nA Senior Design Quality Engineer is responsible for supporting product development teams at iRhythm. In this role you will provide hands-on technical engineering support from concept through commercialization and post-market evaluation. The Senior Design Quality Engineer serves as a core team member on cross-functional hardware, firmware, stand-alone software product development projects and provide expertise and guidance to the team on design control and risk management. In this position, you will play a key role in ensuring that products meet quality standards consistent with iRhythm’s quality processes, and all external design control and regulatory requirements.\nThis position is hybrid in either San Francisco or Cypress, CA (Orange County) with a weekly onsite requirement of 2 days per week\nWhat you’ll be doing:\nContribute to the planning and execution of design controls, risk management, and design verification and validation for iRhythm products.\nParticipate and support the development of product design history file and ensure compliance to internal processes and external standards and regulations.\nPartner with engineering to define design inputs, design outputs, and traceability matrices.\nContribute to the strategy and execution of risk-based design verification and validation.\nParticipate and support the development of product risk management file, to examine and assess the product risks associated with user, design, process, and supplier.\nReview design architectures, selections, requirements, and drawings from early design concepts.\nApply knowledge of IEC 60601, IEC 62366, and IEC 62304 to product development projects.\nServe as a technical resource for assessing validation requirements, solving test-related problems, and developing preventive strategies.\nPerform and lead risk assessments in support of verification and validation activities\nAssist technical teams in the assessment of design changes; including assessment, planning, verification and validation of the change and documentation as required.\nProduce technical reports to support product changes or quality assurance investigations.\nSupport internal and external audits, including preparation and direct interaction with auditors.\nPerform other quality-related duties as assigned.\n What We Need To See\nBachelor’s degree in Computer Science, Software, Computer, Electrical, Mechanical or Biomedical Engineering.\nMinimum of 5 years of experience in Quality Assurance of class II or III products with embedded software in the medical device field.\nDemonstrated competency of 21 CFR 820, ISO13485, ISO14971 and other international standards.\nSolid understanding of design control and risk management from early design and development through commercialization.\nDemonstrated experience with electromechanical systems from concept through launch is preferred.\nProficiency in using tools for documentation, defect tracking, and test management (e.g., Jira).\nAble to navigate the quality system with minimal oversight on projects\nWays to Stand Out\nUnderstands and can subsequently explain complex quality details to non-experts.\nExceptional organizational skills.\nSolves complex problems with minimal oversight.\nBalanced risk-based decision making to drive product quality, gain consensus, and work through technical challenges.\nDemonstrated competency of IEC 62304, and other international standards\nExperience using Master Control, Jira, and JAMA is preferred.\nLocation:\nSan FranciscoActual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.\nEstimated Pay Range\n$138,000.00 - $180,000.00As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.\niRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at \nAbout iRhythm Technologies\niRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.\nMake iRhythm your path forward. Zio, the heart monitor that changed the game.\nThere have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact . Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.\nFor more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121","description_format":"text","description_chars":6421,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Machine Learning","Cardiovascular Devices"],"lifecycle":[{"event":"open","at":"2026-09-26T07:34:36Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 5 · green card filings: 3","filings_12m":5,"filings_prev_12m":10,"green_card_filings_12m":3,"median_offered_wage_usd":150000,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+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":79,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.879,"p_room":0.9,"age_days":20,"expected_fill_days":48,"reasons":["conf:12","velocity","win:mid"],"computed_at":"2026-10-14T06:34:16Z"},"pay":null,"html_url":"https://alion.io/job/irhythm-technologies-senior-design-quality-engineer","json_url":"https://alion.io/job/irhythm-technologies-senior-design-quality-engineer.json","meta":{"generated_at":"2026-10-15T04:46:29Z","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":7004,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-16T00:00:00Z"}},"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":1901464},"rest":"https://alion.io/mcp/rest/get_company?id=1901464"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Firhythm-technologies-senior-design-quality-engineer"},{"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%2Firhythm-technologies-senior-design-quality-engineer"},{"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%2Firhythm-technologies-senior-design-quality-engineer"},{"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/irhythm-technologies-senior-design-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Firhythm-technologies-senior-design-quality-engineer"}]}