Product Test Method Development/Medical Device Drug Systems - Urgent Need (Onsiite) - Millenniumsoft : Job Details

Product Test Method Development/Medical Device Drug Systems - Urgent Need (Onsite)

Join to apply for the Product Test Method Development/Medical Device Drug Systems - Urgent Need (Onsite) role at MillenniumSoft Inc.

Position Details

• Location: Temecula, CA
• Duration: 12 Months
• Hours per week: 40
• Shift: 1st Shift
• Client: Medical Devices Company
• Category: Engineering/Technical
• Experience Level: Entry Level
• Employment Type: Contract on W2 (US Citizens, GC Holders, GC EAD, OPT, EAD, CPT)

Job Description

This position involves developing and validating test methods for drug delivery systems or combination products with minimal supervision. The candidate will work on tests including Design Characterization and Design Verification.

Primary Duties

• Author test methods, protocols, validations, and reports independently
• Plan and perform experiments supporting new product feasibility testing
• Conduct testing following established methods, protocols, and specifications
• Maintain adherence to ZebraSci Quality Systems, including timely reporting of Quality Events
• Communicate project progress and results effectively within teams
• Keep the lab and storage areas organized and clean

Knowledge and Skills

• Understanding of drug-device combination products or medical devices
• Experience with mechanical measurement equipment (Instron, Zwick), vision systems (Keyence), and closure integrity testing
• Experience with test method development and validation (MSA, Gage R&R) preferred
• Proficiency in statistical and analytical methods (Design of Experiments, ANOVA) and software (Minitab, JMP)
• Knowledge of GLP, cGMPs, 21CFR820.30, ISO, ASTM standards is beneficial

Education and Experience

• Bachelor's or Master's degree in Mechanical, Biomedical, Chemical, or relevant engineering field
• 1-5 years of relevant experience for BS degree holders

Additional Details

• Seniority Level: Entry Level
• Employment Type: Full-time

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