Verification and Validation Engineer

Katalyst CRO; Phoenix (AZ); On-site; USD 85,000 - 125,000; Full time

Job summary

Katalyst CRO in Phoenix, AZ is seeking a Verification & Validation (V&V) Engineer (Mechanical) to support Medical Device product development. You will perform design verification and validation testing, create and execute test protocols, and analyze data using Minitab and other statistical tools.

The role collaborates with global operations, NPD, and sustaining engineering to ensure compliant verification methods and maintain the DHF, while managing multiple projects concurrently.

Qualifications

• B.E./B.Tech in Mechanical Engineering or equivalent.
• 4+ years of relevant experience in Medical Device systems.
• Experience performing design verification and validation testing, including test protocol creation/execution.
• Experience analyzing test data using Minitab and other statistical software.
• Knowledge of product stability testing and shelf-life studies for sterile medical products.
• GR&R studies and test method development are a plus.

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 design verification reviews; own the verification/validation portion of the DHF.
• Understand product functionality and perform functional, performance, and packaging testing.
• Collaborate with global operations, NPD, and sustaining engineering teams to harmonize verification methods, protocols, and procedures.
• Demonstrate a complete understanding of standards, equipment, 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 safety regulations and internal policies.
• Execute multiple projects concurrently while effectively managing priorities.

Skills

Cross-functional collaboration

Project management

Attention to detail

Communication

Problem solving

Education

B.E./B.Tech in Mechanical Engineering

Tools

Minitab

Statistical software

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.