Verification and Validation Engineer

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

• We are seeking a Verification & Validation (V&V) Engineer (Mechanical) to support Medical Device product development activities.
• The role involves working with cross-functional teams on new product design and development, performing design verification and validation testing, creating and executing test protocols, analyzing data using Minitab and other statistical tools, and supporting product stability and shelf-life testing for sterile medical products.
• Participate in all phases of new product development and sustaining engineering to understand design intent, intended use, and applicable regulatory standards.
• Plan, create, and execute verification protocols and reports; analyze and summarize results; support formal design verification reviews; and own the verification and validation portion of the Design History File (DHF).
• Understand product functionality and perform functional, performance, and packaging testing.
• Collaborate with global operations, NPD, and sustaining engineering teams to ensure verification methods, protocols, and procedures are harmonized, compliant, and aligned.
• Demonstrate a complete understanding of standards, equipment, tools, gauges, and measurement systems.
• Interpret and analyze design verification data with respect to product performance and operational stability.
• Follow medical device design control processes and ensure compliance with local, federal, international, and internal safety regulations, policies, and procedures.
• Execute multiple projects concurrently while effectively managing priorities.

Job Summary

• We are seeking a Verification & Validation (V&V) Engineer (Mechanical) to support Medical Device product development activities.
• The role involves working with cross-functional teams on new product design and development, performing design verification and validation testing, creating and executing test protocols, analyzing data using Minitab and other statistical tools, and supporting product stability and shelf-life testing for sterile medical products.

Roles & Responsibilities

• Participate in all phases of new product development and sustaining engineering to understand design intent, intended use, and applicable regulatory standards.
• Plan, create, and execute verification protocols and reports; analyze and summarize results; support formal design verification reviews; and own the verification and validation portion of the Design History File (DHF).
• Understand product functionality and perform functional, performance, and packaging testing.
• Collaborate with global operations, NPD, and sustaining engineering teams to ensure verification methods, protocols, and procedures are harmonized, compliant, and aligned.
• Demonstrate a complete understanding of standards, equipment, tools, gauges, and measurement systems.
• Interpret and analyze design verification data with respect to product performance and operational stability.
• Follow medical device design control processes and ensure compliance with local, federal, international, and internal safety regulations, policies, and procedures.
• Execute multiple projects concurrently while effectively managing priorities.

Education & Experience

• B.E./B.Tech in Mechanical Engineering with 4+ years of relevant experience.
• Experience working with cross-functional teams on Medical Device systems with exposure to new product design and development.
• Experience performing design verification and validation testing, including creation and execution of test protocols.
• Experience analyzing test data using Minitab and other statistical software.
• Knowledge and experience in product stability testing and shelf-life studies for sterile medical products.
• Good to Have: Prior experience with GR&R studies and test method development.