Engineer III

Katalyst CRO; Irvine (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking a Design Verification Engineer in Irvine, CA to advance medical device projects through regulated design controls. You will validate test methods, develop fixtures, and generate verification documentation for development-to-launch phases.

The role requires a strong background in Design Verification, IQ/OQ/PQ validation, and statistical methods with experience in ISO 13485/14971 quality systems. Expect collaboration across engineering and QA teams.

Qualifications

• Engineering degree with 5–10 years (BS) or 3+ years (MS).
• Strong expertise in Design Verification for Medical Devices.
• Experience in a regulated environment: 21 CFR 820 and MDR.
• Test equipment validation (IQ, OQ, PQ).
• Statistical analysis experience and documentation (SOPs, reports).
• Proficiency in MS Office, MS Project, SolidWorks, Minitab/JMP.

Responsibilities

• Demonstrate creative out-of-the-box thinking to solve problems and develop new technologies to achieve project goals.
• Design and execute DOE and fixture development to support feasibility, development, and verification stages.
• Define, develop, and validate/transfer test methods.
• Create verification plans, protocols, records, and reports; support investigations and issue resolutions.

Skills

GD&T dimensioning

CAD design (SolidWorks)

Statistical analysis

SOPs and reports

MS Office/Project

Education

B.S. in Engineering

5-10 years experience

Tools

SolidWorks

Minitab/JMP

Job description

• Demonstrate creative 'out of the box' thinking to solve difficult problems and develop new technologies to achieve project goals.
• Design and execute design of experiments and fixture development to support feasibility, development, and verification stages of product development to meet project timelines and all relevant regulatory compliance requirements.
• Define, develop, and validate/transfer test methods.
• Create verification plans, protocols, records, and reports. Support investigations and issue resolutions.

Responsibilities

• Demonstrate creative 'out of the box' thinking to solve difficult problems and develop new technologies to achieve project goals.
• Design and execute design of experiments and fixture development to support feasibility, development, and verification stages of product development to meet project timelines and all relevant regulatory compliance requirements.
• Define, develop, and validate/transfer test methods.
• Create verification plans, protocols, records, and reports. Support investigations and issue resolutions.

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.
• Lean Six Sigma, 5S experience desired.
• Good communication skills, both written and oral. Ability to prepare technical reports and presentations.

What are the top 3-5 skills, experience or education required for this position:

• 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.