Product Development Lab Technician II

Job Overview

Product Development Lab Technician II (temporary). On‑site, Irvine office.

Schedule:

Monday–Friday, 9:00am – 5:00pm PST.

• Perform inspections and testing on raw materials, sub‑assemblies, and finished products to identify non‑conforming material and product.
• Execute routine and non‑routine testing of sub‑assemblies and finished products according to material and product specifications, following Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Compile data for evaluation of departmental Key Process Indicators (KPIs). Assist with validating inspection and testing processes.
• Conduct dimensional inspections on raw materials and incoming components.
• Test prototypes and production products using automated vertical tension and compression machines and flow measurement/pressure systems.
• Develop and maintain lab apparatus, test methods, and documentation for product traceability.
• Maintain performance, calibration, and preventive maintenance records for lab equipment.
• Prepare samples for testing and maintain proper documentation.
• Assist in ordering lab supplies, standards, solvents, and tracking inventory.
• Collaborate with Product Development and Quality engineers to improve testing methodologies and SOPs, increasing lab efficiency.
• Document all work on appropriate forms, laboratory notebooks, and test protocols.
• Comply with safety and operating policies, including handling material safety data sheets (SDS).
• Perform quality material and product measurement, testing, and release using established SOPs and WIs.
• Interpret engineering specifications and drawings, perform inspections, product segregation, and verification.
• Maintain departmental documentation, inventory of measurement equipment, and ensure calibration records are current.
• Perform preventive maintenance on equipment, set‑up/preparation of equipment, cleaning, line changeovers, and general housekeeping.
• Ensure work is performed in compliance with company policies (Privacy/HIPAA, regulatory, legal, and safety requirements).
• Execute verification and validation activities in accordance with QMS, ISO, and FDA standards. Apply GDP, GLP, and GMP.
• Perform additional assignments or projects as directed.

• High school diploma or equivalent required; some post‑high‑school technical training preferred.
• 4+ years of relevant QC inspection experience, preferably in an FDA‑regulated industry.
• Experience with quality system regulations (QSRs) and cGMP, including basic knowledge of QC systems.
• Proficiency with sampling methodologies and tools.
• Experience measuring materials with visual inspection systems.
• Experience with MS Office suite (Word, Excel, Outlook).
• Excellent written and verbal communication skills; ability to work collaboratively as a team member.
• Demonstrated ability to work accurately, follow instructions, and multitask.
• Preferred:
  Experience with medical device consumer products.
• Background check and drug screening required; applicants with arrest or conviction records will be considered per state and local Fair Chance laws.

Starting base pay: $30 per hour. Base pay may vary based on job‑related knowledge, skills, and experience and may fluctuate based on location and market conditions.

Tandem Diabetes Care is an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marital status, pregnancy/maternity, or sexual orientation. Selection for roles is based on individual merit alone.

Applicants must be authorized to work in the U.S. for any employer; no work‑visa sponsorship is available at this time.