{"id":1270694,"url":"https://alion.io/job/edwards-lifesciences-principal-chemist","title":"Principal Chemist","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":"Science & Research","role_family":"Science & Research","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Draper, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":68000,"max_usd":180000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":584},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Chromatography","optional":false},{"name":"GLP","optional":false},{"name":"GMP","optional":false},{"name":"HPLC","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Mass Spectrometry","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-25T23:56:55Z","employer_posted_date":"2026-09-25","last_verified_at":"2026-10-21T12:52:19Z","board_verified":true,"closed_at":null,"days_open":25,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":25},"description":"Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.\nThis is an opportunity to join a state-of-the-art medical device chemical characterization laboratory and center of excellence for analytical chemistry and unknowns analysis. The Principal Chemist will specialize in mass spectrometry-based structural elucidation of extractables and leachables and the development, validation, optimization, and troubleshooting of analytical methods using liquid chromatography mass spectrometer (LC-MS and gas chromatography mass spectrometer (GC-MS), with inductively coupled mass spectrometer (ICP-MS) and related technologies supporting broader chemical characterization and complex investigations.\nHow you’ll make an impact:\nSupport the test method development, validation, and testing on Extractables and Leachables using high performance liquid chromatography mass spectrometer (HPLC-MS), GC-MS, and ICP-MS.\nPerform mass spec structural elucidation of extractables and leachables.\nSupport routine analysis of leachables and extractables and EO/ECH residual on medical device.\nAssist in test method development and validation for a variety of cleaning validations using GC-MS, GC-MS/HS, HPLC-MS, HPLC-DAD, ICP-MS, TOC, FT-IR, UV, etc.\nOwn technical direction for complex laboratory methods, instrumentation platforms, and investigation approaches across multiple workstreams. Provide technical oversight for complex testing, data review, and qualification strategies for new or modified devices and/or processes.\nProvide technical authority for root cause analysis of product/sample failures and Out-of-Specifications (OOS), incidents, deviations and their significance, non-conformances, and CAPA; review technical conclusions, resolve escalated issues, and determine appropriate corrective and preventive actions.\nEstablish technical expectations and execute development, modification, verification, validation, transfer, and lifecycle management of methods, lab-specific protocols, and reports in collaboration with intra- and inter-departmental teams.\nDefine technical strategy for equipment qualifications and software validation activities for complex analytical systems and ensure alignment to laboratory and quality requirements.\nEstablish expectations and perform interpretation of data and analysis of results, including statements of conformity or opinions and interpretations, trend analysis, and qualification strategies for new or modified devices and/or processes.\nLead standardization of laboratory practices, technical decision-making, and review expectations across assigned methods, platforms, or programs.\nLead complex process improvement projects (e.g., BEST, 6S, Lean), update procedures/forms, support safety and quality initiatives, and implement sustainable changes with management approval.\nMentor and technically guide lower-level or new employees; report, review and authorize results; assess work techniques and provide feedback on procedures, methods, and technical rigor.\nWhat you’ll need (Required):\nBachelor's Degree in Chemistry or equivalent with 8 years of previous related experience with unknowns analysis using mass spectrometry techniques and/or structural elucidation; OR\nMaster's Degree in Chemistry or equivalent with 6 years of previous related experience with unknowns analysis using mass spectrometry techniques and/or structural elucidation; OR\nPh.D. or equivalent in Chemistry or equivalent with 4 years of previous related experience with unknowns analysis using mass spectrometry techniques and/or structural elucidation.\nOn-site presence required to collaborate cross-functionally and support manufacturing operations.\nTravel requirement up to 25%.\nWhat else we look for (Preferred):\nExtensive knowledge and understanding of chemical principles, theories and concepts.\nExtensive knowledge of laboratory equipment (e.g., gas Chromatography, high performance liquid chromatography, total organic carbon, fourier transform infrared spectroscopy, atomic absorption).\nFull knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, GLP/GMP/QSIT).\nKnowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.\nProven successful project management skills.\nProven expertise in MS Office; Analytical Equipment System (e.g., ChemStation, MassHunter).\nExcellent communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.\nEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.","description_format":"text","description_chars":5290,"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":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cardiovascular Devices","Patient Monitoring"],"lifecycle":[{"event":"open","at":"2026-09-25T23:56:55Z"}],"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":40,"band":"fade","label":"Fading","p_open":1,"p_active":0.531,"p_room":0.75,"age_days":25,"expected_fill_days":27,"reasons":["conf:3","stale_co","velocity","win:late","comp:brand"],"computed_at":"2026-10-21T05:46:15Z"},"pay":null,"html_url":"https://alion.io/job/edwards-lifesciences-principal-chemist","json_url":"https://alion.io/job/edwards-lifesciences-principal-chemist.json","meta":{"generated_at":"2026-10-21T17:48:37Z","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":25189,"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-principal-chemist"},{"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-principal-chemist"},{"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-principal-chemist"},{"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-principal-chemist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fedwards-lifesciences-principal-chemist"}]}