{"id":1330512,"url":"https://alion.io/job/jenavalve-staff-engineer-i-thv-research-and-development-thv","title":"Staff Engineer I, THV Research and Development-THV","company":{"id":3783838,"name":"JenaValve","domain":"jenavalve.com","url":"https://alion.io/company/trilogy-3","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Paycom","truth_index":null},"role":"Backend","role_family":"Backend","seniority":"staff","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":null,"salary_estimate":{"min_usd":157000,"max_usd":292000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1500},"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"ISO 13485","optional":false},{"name":"SolidWorks","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-09-27T09:30:37Z","employer_posted_date":"2026-10-24","last_verified_at":"2026-11-03T06:55:56Z","board_verified":true,"closed_at":null,"days_open":36,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":36},"description":"Job Title: Staff Engineer, THV Research and Development\nStaff Engineer I, Research and Development\nStaff Engineer II, Research and Development\nStaff Engineer III, Research and Development\nSupervisor/Manager Title: Director, Research and Development\nJob Description Summary: Responsible for the development of novel subsystems and components for transcatheter heart valves and/or delivery systems.\nJob Responsibilities:\nConceive, design, and develop components and subsystems of moderate/high complexity for transcatheter heart valves and/or delivery systemsin accordance with quality system requirements and with minimal supervision.\nCreate, review and/or approve component and subsystem drawings/specifications and documentation.\nIdentify/evaluate vendors, procure components and develop component specifications.\nDevelop test methods, conduct testing, and interpret data.\nConduct engineering analyses and feasibility testing of components and subsystems to ensure proper fit and function.\nConduct competitive product evaluation and product failure analyses.\nPartner with Quality to conduct risk analyses and develop/execute design verification activities.\nPartner with Manufacturing to develop manufacturing processes, tooling/fixtures, and transfer product/processes to manufacturing.\nSupervise R&D Technicians.\nQualifications\nRequired Education and Experience:\nA Bachelor of Science degree in Engineering or Technical discipline with related work experience.\nMinimum of 6+ years’ experience in R&D or product development of medical devices, pharmaceutical or life science product technology. Level I, II, III DOE\nFamiliarity with 21CFR820 and ISO 13485 requirements. \nKnowledge of the product development process and applicable Quality System requirements in the medical device industry.\nDemonstration of ability to work effectively and collaborate within cross-functional teams.\nDemonstration of ability to effectively communicate (in oral presentation and written documentation) test protocols, reports, and technical summaries to technical and non-technical personnel.\nHands-on experience in product development within an R&D lab environment.\nSkills and Abilities Required for This Job:\nAbility to work independently and in collaboration within cross-functional teams.\nAbility to manage multiple tasks in a timely manner with high attention to detail.\nAbility to build strong relationships at all levels of the organization, cross-functionally and with key external personnel.\nDemonstrated strength in problem analysis, judgment, decision making and critical thinking\nStrong 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