{"id":1943794,"url":"https://alion.io/job/jenavalve-senior-engineer-i-thv-manufacturing","title":"Senior Engineer I, THV Manufacturing","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":"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":null,"salary_estimate":{"min_usd":90000,"max_usd":169000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":5966},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Statistical Process Control","optional":false},{"name":"GMP","optional":true},{"name":"SolidWorks","optional":true}],"status":"live","first_seen_at":"2026-10-06T05:00:08Z","employer_posted_date":"2026-10-06","last_verified_at":"2026-10-19T23:24:51Z","board_verified":false,"closed_at":null,"days_open":15,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":15},"description":"Job Title: Senior Engineer, THV Manufacturing\nSenior Engineer I, THV Manufacturing\nSenior Engineer II, THV Manufacturing\nSenior Engineer III, THV Manufacturing\nSupervisor/Manager Title: Senior Global Manager, Manufacturing Engineering\nJob Description Summary: Responsible for manufacturing engineering tasks associated with sustaining clinical/commercial valve (THV) production line.\nJob Responsibilities:\nProvide real-time production line support, such as daily GEMBA walks, equipment troubleshooting, daily tiered meetings, material review board.\nDevelop and optimize manufacturing processes to increase efficiency and quality of products, using lean manufacturing engineering principles.\nDevelop training and documentation materials (e.g., work instructions) for production to enable the seamless transfer of new product/processes to manufacturing.\nGenerate, analyze and summarize data to identify improvement opportunities or to determine appropriate limits and variables for product and process. Perform Corrective and Preventative Action investigations to determine root causes for identified defects and/or trends.\nLead short-term and long-term manufacturing process improvement activities/projects.\nSupport equipment, tooling, and fixture design for development and production activities.\nDocument and manage non-standard manufacturing build requests from cross-functional groups (R&D, Quality) on the production line; provide manufacturing engineering support from production planning, procedure redlines, operator training, through to completion of builds.\nPerform process characterization and validation, under the guidance of a project leader or more senior engineer.\nConfront issues in a constructive manner and at an appropriate organizational level and persevere in the face of adversity.\nMake risk-based decisions to ensure identified issues are assessed and resolved in a way that support JenaValve’s commitment to product quality, regulatory compliance and product availability.\nQualifications\nRequired Education and Experience:\nA Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree).\nMinimum of 4 years’ experience in Medical Device Development or Manufacturing environment is required. Level I, II, II DOE.\nKnowledge of equipment and process qualification (IQ/OQ/PQ) in the medical device industry or other regulated industries is required.\nKnowledge of statistical process control and sampling plans is required. Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.\nSix Sigma and/or Lean Manufacturing experience required; Lean Six Sigma certification preferred.\nKnowledge and experience in Work Instruction creation and implementation. \nPreferred Qualifications:\nMedical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional access devices is preferred.\nExperience in designing and implementing fixturing from design concept to a clinical/commercial production line. \nExperience in implementing equipment from parameter/settings origin to the production line.\nSkills and Abilities Required for This Job:\nMust be able to work effectively and collaborate within cross-functional teams.\nMust take initiative, communicate status and objectives and be able to conduct hands-on work.\nEffective communication and project management skills are required.\nMust be able to handle multiple tasks with high attention to detail.\nMust have strong documentation skills.\nKnowledge of and experience in compliance with GMP and Regulatory procedural standards in a medical device environment.\nExperience in the use of CAD packages (SolidWorks preferable).\nStrong interpersonal and intercultural skills are required.\nAbility to work across various time zones and to travel up to 10%.","description_format":"text","description_chars":3865,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Science & Engineering"],"lifecycle":[{"event":"open","at":"2026-10-06T05:00:08Z"}],"visa":[],"liveness":{"score":69,"band":"ok","label":"Likely open","p_open":1,"p_active":0.765,"p_room":0.9,"age_days":15,"expected_fill_days":27,"reasons":["conf:30","win:mid"],"computed_at":"2026-10-21T05:46:15Z"},"pay":null,"html_url":"https://alion.io/job/jenavalve-senior-engineer-i-thv-manufacturing","json_url":"https://alion.io/job/jenavalve-senior-engineer-i-thv-manufacturing.json","meta":{"generated_at":"2026-10-22T03:09:30Z","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":2835,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"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":3783838},"rest":"https://alion.io/mcp/rest/get_company?id=3783838"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fjenavalve-senior-engineer-i-thv-manufacturing"},{"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%2Fjenavalve-senior-engineer-i-thv-manufacturing"},{"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%2Fjenavalve-senior-engineer-i-thv-manufacturing"},{"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/jenavalve-senior-engineer-i-thv-manufacturing\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fjenavalve-senior-engineer-i-thv-manufacturing"}]}