Associate Technician (Sewing Assembly)

Acara Solutions, Inc.; Irvine (CA); On-site; USD 46,000 - 63,000; Full time

Job summary

Acara Solutions is seeking an Associate Technician for sewing assembly in Irvine, CA. This contract-to-direct role involves precise sewing, tissue preparation, and strict adherence to GMP and cleanroom standards.

The candidate should have at least 2 years sewing heart valves and be comfortable working in a regulated manufacturing environment with detailed documentation and collaboration across teams.

Qualifications

• High School Diploma or GED required.
• Minimum 2 years sewing heart valves experience.
• Ability to work in a cleanroom environment.

Responsibilities

• Perform sewing and tissue preparation steps for valve assembly.
• Verify completed steps against specifications and document results.
• Follow SOPs and record traceable information in device history records.
• Support operations and assist Engineering in root cause analysis of nonconformance.
• Maintain GMP and regulatory compliance in a cleanroom setting.
• Attend full scheduled shifts and overtime as needed to meet production needs.
• General housekeeping and team collaboration.

Skills

Manual dexterity

Attention to detail

Cleanroom experience

English communication

Reading specifications

Education

High School Diploma or GED

Tools

Small hand tools

Job description

Job Title: Associate Technician (Sewing Assembly)

Location: Irvine, CA

Employment Type: Contract to Direct

Industry: Medical Device Assembly

Compensation: $22 - $30.40 based on level of experience

Schedule: Monday - Friday | 1st & 2nd shift

Hours: 5:15am - 1:45pm | 2:30pm - 11:00pm

About the Opportunity:

Manufacturing 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.

Why You'll Love Working Here:

• Supportive, team-driven culture that values collaboration, transparency, and accountability
• Opportunity to grow your career with a global workforce solutions leader serving multiple industries
• People-first environment that encourages employees to bring their authentic selves to work
• Strong focus on partnership, innovation, and delivering meaningful results for clients and candidates

Why This Opportunity is Exciting:

This role offers the chance to join a company that prioritizes both people and performance-where your contributions directly impact client success while giving you room to grow and develop professionally.

About Acara Solutions

Acara is a premier recruiting and workforce solutions provider-we help companies compete for talent. With a legacy of experience in various industries worldwide, we partner with clients, listen to their needs, and customize visionary talent solutions that drive desired business outcomes. We leverage decades of experience to deliver contingent staffing, direct placement, executive search, and workforce services worldwide.

What You'll Do:

Use tools - needles, scissors, forceps, specialized tooling, microscope - to perform assigned steps, in rotation, in the sewing assembly of valves.

• Perform verifications, against specifications, of completed steps, and execute work in assembly line.
• 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.
• Other incidental duties: General work area housekeeping.

Job Requirements

What You'll Bring:

• High School Diploma or GED
• Minimum 2 years' experience sewing heart valves

What Sets You Apart:

• Ability to use small hand tools, steady hand-eye coordination, and high manual dexterity/fine motor skills.
• Must have ability to perform detailed tasks accurately.
• Must be able to work in a cleanroom environment
• 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 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.

Additional Information:

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.

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct) are an Equal Opportunity Employer. Race/Color/Gender/Religion/National Origin/Disability/Veteran.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.