Description
Directly support the commercialization of a newly FDA-approved, life-saving cardiovascular deviceGain exposure to quality, manufacturing, and engineering teams within a Class III device environmentOpportunity to build experience in structural heart / catheter-based technologies, a highly specialized and in-demand spacePerform in-process, functional, and final inspections of transcatheter heart valve (THV) devicesConduct microscope-based inspection of valve components and assembliesExecute functional and hydrodynamic testing related to valve performanceReview and audit Device History Records (DHRs), manufacturing documentation, and process logsSupport sterilization preparation activities and ensure product readiness for final releaseInspect final packaging and labeling to ensure compliance with specifications and quality standardsIdentify defects, document findings, and escalate quality issues as neededMaintain accurate documentation in compliance with GMP, GDP, and quality system requirementsPartner with Engineering by collecting and documenting data on product performance and functionalityContribute 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 equivalentExperience in medical device, pharmaceutical, or sterile manufacturing environmentsFamiliarity with 21 CFR 820 or ISO 13485Experience with DHR review, GDP documentation, or final product release processesExposure to fluid-based or functional testing environments
Experience Level
Intermediate Level
Job Type & LocationThis 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)
This is a fully onsite position in Irvine,CA.
Application Deadline This position is anticipated to close on Jun 15, 2026.About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions.We help visionary companies advance their engineering and science initiatives throughaccess to specialized experts who drive scale, innovation and speed to market.With a network of almost 30,000 consultants and more than 4,500 clients across the U.S.,Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.
If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email ... for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.