Job Details

Sewing Operator

We are seeking a skilled Sewing Operator to join our team in the production of medical devices. You will apply your sewing skills and dexterity to work with both tissue and non-tissue components. This role involves adhering to regulatory and company guidelines, using various tools, and performing specific steps in the sewing assembly of valves. You will also be responsible for tissue processing, verification against specifications, and maintaining compliance with established work instructions and SOPs.

Responsibilities

• Apply skill and dexterity in the sewing of tissue and non-tissue components to produce medical devices.
• Use tools such as needles, scissors, forceps, specialized tooling, and a microscope to perform assigned steps in the sewing assembly of valves.
• Execute receiving, trimming, fixation, die cutting, and measurements for Porcine Pericardium tissue following released procedures.
• Utilize equipment like fume hoods, Litematic, and presses for tissue processing.
• Perform verifications against specifications for completed steps and execute work in an assembly line.
• Review, follow, and perform job functions in compliance with established work instructions and adhere to SOPs, including recording traceable information on device history records.
• Support activities related to other work procedures as requested to support operations processes.
• Assist Engineering in root cause analysis investigations for component nonconformance.

Essential Skills

• Proficient sewing skills and experience.
• Experience working in a cleanroom environment.
• Microscope usage proficiency.
• Assembly and inspection skills.

Additional Skills & Qualifications

• High School Diploma.
• Previous experience in sewing, cleanroom, and medical device production.
• Experience with microscope operations.

Why Work Here?

Join a growing company where you will have the opportunity to develop your skills in a supportive and dynamic environment. We offer a collaborative workplace where your contributions will be valued, and you can be part of a team dedicated to producing high-quality medical devices.

Work Environment

You will be working in a cleanroom environment, utilizing various specialized tools and equipment. The role involves adherence to strict regulatory guidelines and standard operating procedures to ensure the highest quality in medical device production.

Job Type & Location

This is a Contract to Hire position based out of Irvine, California.

Pay and Benefits

The pay range for this position is $18.00 - $25.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Irvine,CA.

Application Deadline

This position is anticipated to close on Apr 4, 2025.