{"id":1330513,"url":"https://alion.io/job/jenavalve-technician-thv-sewing-2nd-shift","title":"Technician, THV Sewing (2nd Shift)","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":"Field & Service","role_family":"Field & Service","seniority":null,"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":40000,"max_usd":90000,"period":"year","method":"role_country_seniority_unknown","sample_n":18483},"experience_years_min":null,"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":"2026-10-19T23:24:51Z","board_verified":true,"closed_at":null,"days_open":23,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":23},"description":"Job Title: Technician, THV Sewing\nTechnician I, THV Sewing\nTechnician II, THV Sewing\nTechnician III, THV Sewing\nRole Level: Individual Contributor\nSupervisor/Manager Title: Associate Manager, THV Production and Technical Training\nJob Location & Environment: Irvine, CA - Corporate Office / Controlled Cleanroom Environment\nJob Description Summary:\nManufacturing - Hourly / Assembly / Inspection.\nManufacturing technician responsible for performing detailed sewing and tissue preparation processes used in the assembly of transcatheter heart valve devices. This role requires high manual dexterity, attention to detail, and adherence to strict regulatory, quality, and contamination control procedures within a controlled cleanroom manufacturing environment.\nJob Responsibilities:\nUse tools - needles, scissors, forceps, specialized tooling, microscope - to perform assigned steps, in rotation, in the sewing assembly of valves.\nPerform verifications, against specifications, of completed steps, and execute work in assembly line.\nReview, follow, and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.\nSupport activities correspond to other work procedures, as requested, to provide support to operations processes.\nAssist Engineering in root cause analysis investigation for component nonconformance.\nMaintain compliance with company Quality Management System requirements, including applicable Good Manufacturing Practices (GMP) and regulatory standards.\nMaintain reliable and consistent attendance to support production operations, including punctual arrival and the ability to work full scheduled shifts and overtime as required to meet operational and production needs.\nOther incidental duties: General work area housekeeping.\nQualifications\nRequired Education and Experience:\nThe level of this role (Technician I, II, or III) will be determined based on the candidate’s experience, technical skills, and demonstrated competencies relevant to the position. \nSpecific expectations for each level are further defined in the Technical & Operational Competency Matrix. \nHigh school diploma or equivalent required. Candidates without a diploma may demonstrate equivalent competency through a validated external assessment designed to evaluate comprehension, language, and related abilities at a high school level.\nExperience in regulated/ cleanroom production environments preferred. \nTechnician I:\nPerforms standard production tasks independently while following established work instructions, SOPs, and safety requirements with consistent accuracy and reliability.\nMaintains required productivity and quality standards while completing documentation and process steps with minimal errors.\nCommunicate effectively with team members and supervisors while contributing to a collaborative work environment and maintaining reliable attendance and professional conduct.\nPerform verifications, according to specifications, of completed steps, as well as successive reviews of steps performed by team members on their own\nIs able to perform a minimum of three sections of the heart valve manufacturing with minimal trainer or lead verification.\nTechnician II:\nExecutes more complex production tasks with increased efficiency and accuracy while ensuring adherence to SOPs, quality standards, and safety practices.\nIdentifies minor process issues or deviations and communicates them appropriately to leads or supervisors to support continuous improvement and operational reliability.\nActively supports team performance through effective communication, consistent productivity, and reliable documentation of manufacturing activities.\nPerform verifications, according to specifications, of completed steps, as well as successive reviews of steps performed by team members on their own\nIs able perform more than three sections of the heart valve manufacturing with minimal trainer or lead verification.\nTechnician III:\nDemonstrates mastery of production operations and independently performs complex or specialized tasks while maintaining high standards of quality, safety, and productivity.\nApplies strong process knowledge to ensure accurate execution of procedures, assist with troubleshooting, and help prevent recurring errors.\nServes as a trusted technical resource to peers by sharing best practices, supporting team coordination, and maintaining exemplary reliability and professionalism.\nPerform verifications, according to specifications, of completed steps, as well as successive reviews of steps performed by team members and ability to provide feedback to coworkers\nIs able to perform all of the steps of the heart valve manufacturing with minimal trainer or lead verification.\nSkills and Abilities Required for This Job:\nAbility to use small hand tools, steady hand-eye coordination, and high manual dexterity/fine motor skills.\nMust have ability to perform detailed tasks accurately.\nMust be able to handle animal tissue and wet processes.\nMust be able to work effectively and collaborate within cross functional teams.\nAbility to read, comprehend and speak English, and good communication skills required.\nKnowledge of and adherence to Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.\nSuccessful completion of required training and demonstrated competency on assigned manufacturing processes. \nAdhere to all rules and requirements 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.\nBasic computer skills.\nPhysical Requirements:\nAbility to work in a controlled cleanroom environment while wearing full cleanroom gowning including gown/coveralls, gloves, mask, hairnet, boot covers, and other PPE as needed.\nAbility to perform highly detailed sewing operations while seated for extended periods during the work shift.\nAbility to maintain sustained concentration while performing intricate work under a microscope or magnification.\nAbility to use hands and fingers for fine manipulation of small components.\nAbility to perform work requiring close visual acuity.\nAbility to follow strict safety, contamination control, and cleanroom protocols.\nMust be able to stand, walk, and sit for prolonged periods of time.\nMust be able to push, pull, twist, climb, balance, stoop, kneel, and crawl.\nMust be able to perform repetitive motions such as reaching and grasping.\nAbility to lift or move materials up to 25 pounds.","description_format":"text","description_chars":6632,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Science & 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