{"id":1199797,"url":"https://alion.io/job/edwards-lifesciences-senior-engineer-npd-quality-3","title":"Senior Engineer, NPD Quality","company":{"id":5220,"name":"Edwards Lifesciences","domain":"edwards.com","url":"https://alion.io/company/edwards","size_band":"5000+","is_staffing_agency":false,"is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":78,"open_postings":36,"ghost_share":0,"stale_share":0.861,"repost_share":0.028,"time_to_fill_p50_days":24,"computed_at":"2026-09-24T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","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":108000,"max":153000,"currency":"USD","period":"year","gross":null,"usd_annual":153000},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-24T20:14:08Z","employer_posted_date":"2026-09-24","last_verified_at":"2026-09-24T07:07:07Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.\nThis Principal Quality Engineer, NPD will be part of Edwards Lifesciences growing Transcatheter Heart Valve (THV) business in Irvine, CA. We are looking for a strong engineer with solid technical expertise, who enjoys working in a fast paced and rapidly growing environment where taking initiative and collaborating cross-functionally are critical for success. The engineer will have a variety of responsibilities in New Product Development providing Quality Engineering support and leadership to ensure the successful design and development of new products. You will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to oversee quality for new product development.\nHow you will make an impact:\nDevelop, update, and maintain design control documentation through product development processes. Support development of design requirement documentation.\nDevelop, update, and maintain technical content of risk management and usability files\nCollaborate with R&D, manufacturing, and other cross-functional stakeholders to drive process and/or test method development, product builds, clinical programs, design transfer, and product launch. Participate in design verification and validation testing.\nInvestigate complex product quality and compliance issues (e.g., pre-commercial complaints, CAPA, non-conformances, audit observations, PRAs) during new product development based on engineering principles; analyze results, make recommendations and develop reports.\nIdentify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes and/or test methods and reduce risk.\nAssign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. Train, coach, and guide lower-level employees on routine procedures\nOther incidental duties assigned by Leadership\nWhat you’ll need (Required):\nBachelor's Degree in Engineering or Scientific field with 4 years’ experience related industry experience or\nMaster's Degree or equivalent in Engineering or Scientific field with 3 years’ experience related industry or industry/education experience or\nPh.D. or equivalent in Engineering or Scientific field with industry experience or industry/education\nWhat else we look for (Preferred):\nProven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)\nStrong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills\nBasic understanding of statistical techniques\nPrevious experience working with lab/industrial equipment required (if applicable)\nSubstantial understanding and knowledge of principles, theories, and concepts relevant to Engineering\nStrong problem-solving, organizational, analytical and critical thinking skills\nSubstantial understanding of processes and equipment used in assigned work\nGood leadership skills and ability to influence change\nKnowledge of applicable FDA regulations for medical device industry\nStrict attention to detail\nAbility to interact professionally with all organizational levels\nAbility to manage competing priorities in a fast paced environment\nMust be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects\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 $108,000 - $153,000 (highly experienced). The 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":5292,"description_truncated":false,"requirements":{"experience_years_min":4,"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":["Health Care","Medical Devices","Medical Imaging"],"lifecycle":[{"event":"open","at":"2026-09-24T20:14:08Z"}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":24,"reasons":["conf:1","win:early","comp:brand"],"computed_at":"2026-09-24T21:37:34Z"},"pay":{"stated_usd_annual":153000,"is_top_pay":false},"html_url":"https://alion.io/job/edwards-lifesciences-senior-engineer-npd-quality-3","json_url":"https://alion.io/job/edwards-lifesciences-senior-engineer-npd-quality-3.json","meta":{"generated_at":"2026-09-24T21:37:34Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}