Engineer III

Katalyst CRO; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO in Irvine, CA seeks a Senior Design Verification Engineer to drive verification for medical device programs. You will design experiments, develop fixtures, and transfer test methods to meet project timelines while ensuring 21 CFR 820 and MDR compliance.

The role requires a BS (or MS) in engineering with substantial design verification experience, proficiency in SolidWorks and statistical tools, and strong communication for technical reports and cross-functional collaboration.

Qualifications

• BS or MS in engineering with years of experience as specified in the requirements.
• Experience in medical device design verification and regulatory compliance (21 CFR 820 / MDR).
• Experience documenting SOPs, technical reports, and verification plans/protocols/reports.

Responsibilities

• Demonstrate out-of-the-box thinking to solve problems and develop new technologies.
• Design and execute experiments and fixture development for feasibility and verification.
• Define, develop, and validate transfer/test methods.
• Create verification plans, protocols, records, and reports; support investigations.

Skills

Design Verification

Statistical analysis

Documentation & SOPs

Technical reporting

Communication skills

Education

BS in Mechanical Engineering or related field

MS in Mechanical Engineering or related field

Tools

SolidWorks

Minitab

JMP

MS Office

MS Project

GD&T

Job description

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.