Senior Technician, THV Sewing

Jenavalve Technology; Irvine (CA); On-site; USD 34,550 - 49,207; Full time

Job summary

Jenavalve Technology is seeking a Senior Technician in Irvine, CA, to perform detailed sewing processes for transcatheter heart valve devices. You will ensure compliance with strict quality and safety standards in a cleanroom environment.

The role requires a high school diploma, strong manual dexterity, and previous experience in biological tissue processing. This is a full-time position, offering a salary of $30.40 hourly.

Qualifications

• Previous biological tissue processing, GMP, cleanroom experience required.
• Ability to handle animal tissue and wet processes.
• Strong technical proficiency and collaboration skills necessary.

Responsibilities

• Perform detailed sewing and assembly of heart valve devices.
• Maintain adherence to safety and quality standards.
• Assist in training and certify others.

Skills

High manual dexterity

Attention to detail

Effective communication

Ability to follow safety protocols

Basic computer skills

Education

High school diploma or equivalent

Tools

Microscope

Specialized tooling

Job description

Job Title

Senior Technician, THV Sewing

Job Details

• Location: Irvine, CA 92618
• Position Type: Full Time
• Education Level: High School
• Salary: $30.40 - $30.40 Hourly

Job Summary

Manufacturing – Hourly / Assembly / Inspection. The manufacturing technician is responsible for performing detailed sewing and tissue preparation processes used in the assembly of transcatheter heart valve devices. Requires high manual dexterity, attention to detail, adherence to strict regulatory, quality, and contamination control procedures within a controlled cleanroom manufacturing environment.

Job Responsibilities

• Use tools (needles, scissors, forceps, specialized tooling, microscope) to perform assigned steps of sewing and valve assembly.
• Perform verifications against specifications of completed steps and execute work on the assembly line.
• Review, follow, and perform job functions in compliance with established work instructions and SOPs, including recording traceable information on device history records.
• Support activities that 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 GMP and regulatory standards.
• Maintain reliable and consistent attendance to support production operations, including punctual arrival and ability to work full scheduled shifts and overtime as required.
• Complete training as outlined in Training Plans and ability to train and certify others.
• 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.

Qualifications

The level (Senior Technician I, II or III) will be determined based on the candidate’s experience, technical skills, and demonstrated competencies. 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.

Previous biological tissue processing, GMP, cleanroom, medical device experience required.

Senior Technician I

• Highly skilled at performing production tasks independently while following established work instructions, SOPs, and safety requirements with consistent accuracy and reliability.
• Maintains consistent productivity and quality standards while completing documentation and process steps with minimal errors.
• Identifies minor process issues or deviations and communicates them appropriately to leads or supervisors to support continuous improvement and operational reliability.
• Communicates effectively with team members and supervisors while contributing to a collaborative work environment and maintaining reliable attendance and professional conduct.
• Performs verifications, according to specifications, of completed steps, and successive reviews of steps performed by team members, providing feedback.
• Trusted technical resource; supports peers informally.
• Sews all parts of the valve and identifies errors, correcting them with minimal lead verification.
• Able to perform additional sewing activities like kitting, serial tag attachment, and overall reworking.

Senior Technician II

• Shows expertise at performing production tasks independently while following established work instructions, SOPs, and safety requirements with consistent accuracy and reliability.
• Identifies process issues or deviations and recommends corrections, communicating accordingly.
• Performs verifications, according to specifications, of completed steps, and successive reviews of steps performed by team members, providing feedback.
• Trusted technical resource; prevents recurring issues and influences peers and provides guidance.
• Sews all parts of the valve and identifies errors, correcting them with minimal to no lead verification.
• Able to perform additional sewing activities like kitting, serial tag attachment, and overall reworking.
• Exceptional reliability and professionalism; consistently meets or exceeds attendance and timekeeping expectations; actively reinforces workplace standards.

Senior Technician III

• Recognized authority in area; independently handles rare or complex issues and sets best practices.
• Identifies process issues or deviations and recommends corrections, communicating accordingly, and sets standards for quality and efficiency.
• Performs verifications, according to specifications, of completed steps, and successive reviews of steps performed by team members, providing feedback.
• Trusted advisor; sets technical standards; provides guidance and influences without formal authority.
• Sews all parts of the valve and identifies errors, correcting them with minimal to no lead verification.
• Able to perform additional sewing activities like kitting, serial tag attachment, support BDC operations and overall reworking.
• Exceptional reliability and professionalism; consistently meets or exceeds attendance and timekeeping expectations; actively reinforces workplace standards.

Skills and Abilities Required

• Advanced technical proficiency and play a key role in maintaining production quality, supporting team development, and ensuring consistent process execution.
• Ability to use small hand tools, steady hand-eye coordination, and high manual dexterity/fine motor skills.
• Ability to follow strict safety, contamination control, and cleanroom protocols.
• Must be able to perform detailed tasks accurately.
• Must be able to handle animal tissue and wet processes.
• 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 cleanroom 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 the protection of environment and prevention of pollution under their span of influence/control.
• Basic computer skills.

Physical Requirements

• Ability to work in a controlled cleanroom environment while wearing full cleanroom gowning including gown/coveralls, gloves, mask, hairnet, boot covers, and other PPE.
• Ability to perform highly detailed sewing operations while seated for extended periods during the work shift.
• Ability to maintain sustained concentration while performing intricate work under a microscope or magnification.
• Ability to use hands and fingers for fine manipulation of small components.
• Ability to perform work requiring close visual acuity.
• Ability to lift, carry, push, or pull materials and equipment weighing up to approximately 25 pounds.
• Ability to visually inspect small components with or without corrective lenses.
• Ability to work in a temperature‑controlled environment with limited mobility while gowned.
• 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.