Mechanical V&V Engineer for Medical Devices

Katalyst CRO; Little Rock (AR); On-site; USD 75,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Verification & Validation Engineer (Mechanical) to support Medical Device product development. The role involves cross-functional collaboration, performing design verification and validation testing, and creating test protocols with data analysis using Minitab for sterile products.

Responsibilities include managing DHF verification, understanding design intent, and ensuring compliance with global regulatory standards while handling multiple projects concurrently.

Qualifications

• 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.

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.

Skills

Design verification

Validation testing

Cross-functional work

Data analysis

GR&R awareness

Education

B.E./B.Tech in Mechanical Engineering

Tools

Minitab

Job description

Katalyst CRO is seeking a Verification & Validation Engineer (Mechanical) to support Medical Device product development. The role involves cross-functional collaboration, performing design verification and validation testing, and creating test protocols with data analysis using Minitab for sterile products.

Responsibilities include managing DHF verification, understanding design intent, and ensuring compliance with global regulatory standards while handling multiple projects concurrently.