{"id":1330508,"url":"https://alion.io/job/jenavalve-engineer-i-quality-thv","title":"Engineer I, Quality (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":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","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":60000,"max_usd":113000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1752},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-27T09:30:37Z","employer_posted_date":"2026-09-27","last_verified_at":"2026-09-30T19:50:59Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Job Title: Engineer, Quality (THV)\n Engineer I, Quality (THV)\n Engineer II, Quality (THV)\n Engineer III, Quality (THV)\nRole Level: Individual Contributor\nSupervisor/Manager Title: Senior Manager, Quality Engineering\nJob Location & Environment: Irvine, CA- Corporate office / Controlled Cleanroom Environment\nJob Description Summary:\nProvide regular Quality Engineering support to transcatheter Heart Valve (THV) manufacturing and relevant areas including design Verification and Validation, production line/receiving inspection support, process validation (IQ/OQ/PQ), process optimization, non-conformance identification/initiation/investigation, risk management, and post-market assessment.\nJob Responsibilities:\nPartner with Manufacturing Engineers to characterize and qualify manufacturing processes.\nProvide technical Quality support to ensure new processes/procedures are in compliance with the governing standards and procedures. \nReview of documentation and production records to ensure all product is produced in compliance with QSRs and ISO standards and ensure all Device History Records (DHR) are complete, accurate and compliant to Good Documentation Practice (GDP).\nReview and update device Validation Master Plan (VMP)\nCreation and approval of test protocols and reports in support of equipment qualifications (IQ/OQ/PQ), design verification, continuous improvement projects, validation activities and Gage R&R studies.\nCreation and review of technical reports and documentation.\nSupport or lead root cause analysis investigations for production-related or quality-related nonconformities (respectively) and develop and aid in the implementation corrective actions.\nDevelopment and implementation of effective corrections/corrective actions.\nPartner with R&D and Manufacturing Engineers to develop/refine critical manufacturing processes.\nFunction as a core-team member in cross-functional teams in the generation and implementation of improvement projects and process scale-up projects.\nAudit the manufacturing line to ensure compliance to governing procedures is being met.\nSupport Internal and External (supplier) audits.\nSupport elements of the Quality System such as, but not limited to, NCRs, CAPAs and Complaints.\nQualifications\nRequired Education and Experience:\nBachelor of Science degree in engineering or relevant scientific subject required. Biomedical, biochemical or chemical degree is preferred. \nMinimum 2 yearsof medical device Quality/Regulatory experience in a medical device, pharmaceutical or life sciences technology driven company.Level I, II, III DOE.\nExperience with nonconformances, investigations, root cause analysis, risk analysis and corrective/preventive actions.\nMust be familiar with 21CFR820, ISO 13485, and ISO14971 requirements.\nSkills and Abilities Required for This Job:\nMust be able to adhere to company code of conduct and contribute to fostering a professional, collaborative and respectful team working environment.\nAbility to work effectively in a regulated manufacturing / cleanroom environment.\nStrong attention to detail while reviewing documents and records.\nCan identify work priorities and deploy resources to ensure business needs aremet.\nMust be able to work effectively and collaborate within cross-functional teams.\nMust be able to effectively articulate (verbally and in writing) results and conclusions to technical and non- technical personnel.\nMust possess the ability to handle multiple tasks with high attention to detail.\nPhysical Requirements:\nMinimum traveling, less than 10%, required for tooling development and testing.\nMust be able to work in a manufacturing, laboratory, and clean room environment, including compliance with applicable gowning and PPE requirements.\nMust be able to follow clean room, laboratory, and site safety protocols at all times. \nMay require use of inspection and testing equipment as needed.","description_format":"text","description_chars":3897,"description_truncated":false,"requirements":{"experience_years_min":2,"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":["Biotechnology","Health Care","Science & Engineering"],"lifecycle":[{"event":"open","at":"2026-09-27T09:30:37Z"}],"liveness":{"score":77,"band":"hot","label":"Hiring now","p_open":0.9,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":15,"reasons":["conf:64","win:early","comp:junior"],"computed_at":"2026-09-30T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/jenavalve-engineer-i-quality-thv","json_url":"https://alion.io/job/jenavalve-engineer-i-quality-thv.json","meta":{"generated_at":"2026-10-01T03:35:19Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":3098,"day_limit":5000,"remaining_today":1902,"minute_limit":60,"resets_at":"2026-10-02T00:00:00Z"}}}