Mechanical Verification & Validation Engineer for Medical Devices

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

Job summary

Katalyst CRO in San Antonio, TX is seeking a Verification & Validation Engineer (Mechanical) to support medical device product development. You will work with cross-functional teams to perform design verification and validation testing, and to create and execute test protocols.

The role requires interpreting verification data, maintaining DHF elements, and ensuring compliance with local and international safety regulations.

Qualifications

• 4+ years of mechanical V&V experience in medical devices.
• Experience in design verification and validation testing.
• Experience with Minitab and statistical data analysis.
• Knowledge of stability/shelf-life testing for sterile products.
• GR&R studies familiarity is a plus.

Responsibilities

• Plan, execute verification protocols and compile reports.
• Analyze results and support DHF inclusion.
• Perform functional, performance, and packaging tests.
• Collaborate with cross-functional teams to align methods and standards.
• Ensure compliance with applicable medical device regulations.
• Manage multiple projects with competing priorities.

Skills

Cross-functional collaboration

Statistical analysis

V&V knowledge

Education

B.E./B.Tech in Mechanical Engineering

Tools

Minitab

GR&R studies

Job description

Katalyst CRO in San Antonio, TX is seeking a Verification & Validation Engineer (Mechanical) to support medical device product development. You will work with cross-functional teams to perform design verification and validation testing, and to create and execute test protocols.

The role requires interpreting verification data, maintaining DHF elements, and ensuring compliance with local and international safety regulations.