Technician, THV Solutions Mixing (Temp to Hire)

Job Title: Technician, THV Solutions Mixing

• Technician I, THV Solutions Mixing
• Technician II, THV Solutions Mixing
• Technician III, THV Solutions Mixing

Role Level: Individual Contributor

Supervisor/Manager Title: Senior Supervisor, Tissue Processing

Job Location & Environment: Irvine, CA – Corporate Office / Controlled Cleanroom Environment

Job Description Summary:

• Manufacturing - Hourly / Assembly / Inspection.
• Manufacturing technician responsible for preparing chemical solutions, sanitization of items and preparation of salts required to manufacture heart valve devices. Support for manufacturing & R&D tasks associated with new product development and commercialization of transcatheter heart valves.
• This requires attention to detail, and adherence to strict regulatory, quality, and contamination control procedures within a controlled and non-controlled   manufacturing environment

Job Responsibilities:

• Manufacture chemical solutions to be used in the production facility for the valve manufacturing process per approved work instructions.
• Ensure correct manufacture, storage, handling, cleaning and disposition of all products, components, equipment, instruments and solutions per approved work instructions and procedures.
• Sanitize and properly prepare items or components required for the heart valve manufacturing process.
• Participate in shipping and receiving activities of porcine pericardium.
• Support the process and controls for all inventories and raw material supplies.
• Review, follow, and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.
• Support activities correspond to other work procedures, as requested, to provide support to operations processes.
• Assist Engineering in root cause analysis investigation for component nonconformance.
• Maintain compliance with company Quality Management System requirements, including applicable Good Manufacturing Practices (GMP) and regulatory standards.
• Maintain 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.
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others.
• Other incidental duties: General work area housekeeping.
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others.

Required Education and Experience:

• The level of this role (Technician I, II, III) will be determined based on the candidate's experience, technical skills, and demonstrated competencies relevant to the position.
• Specific expectations for each level are further defined in the Technical & Operational Competency Matrix.
• High 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.
• Previous GMP, clean room, medical device experience preferred.

Technician I:

• Performs standard production tasks independently while following established work instructions, SOPs, and safety requirements with consistent accuracy and reliability.
• Maintains required productivity and quality standards while completing documentation and process steps with minimal errors.
• Communicate effectively with team members and supervisors while contributing to a collaborative work environment and maintaining reliable attendance and professional conduct.
• Perform verifications, according to specifications, of completed steps, as well as successive reviews of steps performed by team members on their own
• Show competence on use of balance scale, pH meter, glassware and laboratory items.
• Is able to prepare at least three different solutions per the work instructions with minimal supervision.
• Participates in autoclaving and sanitization activities with minimal supervision.

Technician II:

• Executes more complex production tasks with increased efficiency and accuracy while ensuring adherence to SOPs, quality standards, and safety practices.
• Identifies minor process issues or deviations and communicates them appropriately to leads or supervisors to support continuous improvement and operational reliability.
• Actively supports team performance through effective communication, consistent productivity, and reliable documentation of manufacturing activities.
• Perform verifications, according to specifications, of completed steps, as well as successive reviews of steps performed by team members on their own
• Is able to prepare all the core solutions and at least 2 Jasmine solutions per the work instructions with minimal supervision.
• Participates in tissue receiving tasks and sanitization processes following proper work instructions.

Technician III:

• Demonstrates mastery of solutions mixing operations and independently performs specialized tasks while maintaining high standards of quality, safety, and productivity.
• Maintains required productivity and quality standards while completing documentation and process steps with minimal errors.
• Applies strong process knowledge to ensure accurate execution of procedures, assist with troubleshooting, and help prevent recurring errors.
• Ability to find faults and correct GDP issues with minimal lead or supervisor verification.
• Serves as a trusted technical resource to peers by sharing best practices, supporting team coordination, and maintaining exemplary reliability and professionalism.
• Perform 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.
• Ability to perform all tasks related to Solutions Mixing team with minimal to no supervision from team leader or supervisor.

Skills and Abilities Required for This Job:

• Ability to utilize scale balances, pH meter, and other chemistry related equipment.
• Must have ability to perform detailed tasks accurately.
• Ability to perform basic mathematic operations.
• Must be able to work effectively and collaborate within cross functional teams.
• Ability to read, comprehend and speak English, and good communication skills required.
• Knowledge of and adherence to Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
• Successful completion of required training and demonstrated competency on assigned manufacturing processes.
• Adhere 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.
• Basic computer skills.

Physical Requirements:

• Ability to perform highly detailed chemical solutions preparation while standing for extended periods during the work shift.
• Ability to perform work requiring close visual acuity..
• Ability to work in a controlled and non-controlled environment while wearing full cleanroom gowning including gowns, gloves, mask, hairnet, boot covers, and other PPE as needed.
• Ability to follow strict safety, contamination control, and cleanroom protocols.
• Must be able to stand, walk, and sit for prolonged periods of time.
• Must be able to push, pull, twist, climb, balance, stoop, kneel, and crawl.
• Must be able to perform repetitive motions such as reaching and grasping.

Salary : $20