Medical Device V&V Engineer (Mechanical) - Test & Analysis

Katalyst CRO; San Antonio (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Verification & Validation (Mechanical) Engineer to support Medical Device development. You will join cross-functional teams to execute design verification and validation testing, create test protocols, and analyze data using Minitab for sterile medical products.

Responsibilities include handling DHF verification/validation, understanding design intent, and ensuring compliance with regulatory standards across local and international guidelines.

Qualifications

• B.E./B.Tech in Mechanical Engineering (4+ years of relevant experience).
• Experience with Medical Device product development and cross-functional teams.
• Experience performing design verification and validation testing, including test protocols.
• Experience analyzing test data using Minitab or similar statistical software.

Responsibilities

• Participate in all phases of new product development and sustaining engineering to understand design intent and regulatory standards.
• Plan, create, and execute verification protocols and reports; own the DHF verification/validation portion.
• Perform functional, performance, and packaging testing of products.
• Collaborate with global operations, NPD, and sustaining engineering to harmonize verification methods and procedures.
• Demonstrate understanding of standards, equipment, gauges, and measurement systems.
• Interpret and analyze design verification data with respect to product performance and stability.
• Follow medical device design control processes and ensure compliance with regulations.
• Execute multiple projects concurrently while managing priorities.

Skills

Design verification

Validation testing

Data analysis

Cross-functional collaboration

Statistical software (Minitab)

Education

B.E./B.Tech in Mechanical Engineering

Tools

Minitab

GR&R studies

Job description

Katalyst CRO is seeking a Verification & Validation (Mechanical) Engineer to support Medical Device development. You will join cross-functional teams to execute design verification and validation testing, create test protocols, and analyze data using Minitab for sterile medical products.

Responsibilities include handling DHF verification/validation, understanding design intent, and ensuring compliance with regulatory standards across local and international guidelines.