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Engineering Technician- THV
Job
Actalent
Irvine, CA (In Person)
$62,400 Salary, Full-Time
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Job Description
Description Directly support the commercialization of a newly FDA-approved, life-saving cardiovascular device Gain exposure to quality, manufacturing, and engineering teams within a Class III device environment Opportunity to build experience in structural heart / catheter-based technologies, a highly specialized and in-demand space Perform in-process, functional, and final inspections of transcatheter heart valve (THV) devices Conduct microscope-based inspection of valve components and assemblies Execute functional and hydrodynamic testing related to valve performance Review and audit Device History Records (DHRs), manufacturing documentation, and process logs Support sterilization preparation activities and ensure product readiness for final release Inspect final packaging and labeling to ensure compliance with specifications and quality standards Identify defects, document findings, and escalate quality issues as needed Maintain accurate documentation in compliance with GMP, GDP, and quality system requirements Partner with Engineering by collecting and documenting data on product performance and functionality Contribute to continuous improvement efforts related to THV manufacturing and inspection processes Skills Engineering, Inspection, Troubleshooting, Quality control, Assembly, Production, Gmp, Quality assurance, Mechanical, Schematic, Quality inspection, Packaging, Test equipment Top Skills Details Engineering,Inspection,Troubleshooting,Quality control Additional Skills & Qualifications Bachelors Degree in Engineering, Biomed or equivalent Experience in medical device, pharmaceutical, or sterile manufacturing environments Familiarity with 21 CFR 820 or
ISO 13485
Experience with DHR review, GDP documentation, or final product release processes Exposure to fluid-based or functional testing environments Experience Level Intermediate Level Job Type & Location This is a Contract to Hire position based out of Irvine, CA. Pay and Benefits The pay range for this position is $25.00 - $35.00/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.