Engineer III
Katalyst CRO · Irvine, CA · 3 mo ago
On-siteEngineeringContract
Requirements
- A degree in an engineering field (mechanical, materials, packaging, bioengineering): BS or equivalent education with 5-10 years of experience; MS or equivalent education with 3+ years of experience.
- Strong expertise in Design Verification for Medical Devices and experience working in a regulated environment in compliance to 21 CFR 820 and MDR.
- Significant background in engineering testing and analysis including: Direct experience of test equipment validation (IQ, OQ, PQ) is required.
- Must be able to demonstrate relevant experience in statistical analysis.
- Documentation experience including standard operating procedures (SOPs), technical reports, and design verification plans/protocols/reports.
- Proficiency in MS Office, MS Project, Solidworks, Minitab or JMP.
- Likely Lean Six Sigma, 5S experience desired.
Skills
- Experience creating engineering drawings, proficiency with GD&T dimensioning, CAD design (SolidWorks) and tolerance stack analysis.
- Experience with ISO 13485 and 14971 quality system and risk management principles.
- Experience with design control, DHF documentation, and good manufacturing/documentation practices.
- Experience with fixture design, fixture development, test method validation.
- Experience with statistical software (Minitab or JMP), Six Sigma statistics and Design of Experiments.