Medical Device Mechanical V&V Engineer

Creative Solutions Services, LLC; San Antonio (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Verification & Validation (V&V) Engineer (Mechanical) to support medical device product development. The role involves designing, executing verification protocols, analyzing results with Minitab, and contributing to the DHF.

You will work with cross-functional teams across R&D, manufacturing, and quality to ensure robust verification and validation, including packaging and stability considerations, while upholding design control standards and

Qualifications

• 4+ years of experience in mechanical engineering with medical devices.
• Experience with design verification and validation testing.
• Experience analyzing test data with Minitab or similar software.
• Familiarity with Design History File (DHF) documentation.
• Knowledge of design control processes and regulatory standards.
• Nice to have GR&R studies and test method development.

Responsibilities

• Plan, execute verification protocols and reports; analyze and summarize results; support formal design verification reviews; and own the verification and 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 ensure verification methods, protocols, and procedures are harmonized, compliant, and aligned.
• 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 local, federal, international, and internal safety regulations, policies, and procedures.
• Execute multiple projects concurrently while effectively managing priorities.

Skills

Minitab

Statistical analysis

Design Verification & Validation

Cross-functional collaboration

Test protocols

Measurement systems

Education

B.E./B.Tech in Mechanical Engineering

Tools

Statistical software

Job description

Creative Solutions Services, LLC is seeking a Verification & Validation (V&V) Engineer (Mechanical) to support medical device product development. The role involves designing, executing verification protocols, analyzing results with Minitab, and contributing to the DHF.

You will work with cross-functional teams across R&D, manufacturing, and quality to ensure robust verification and validation, including packaging and stability considerations, while upholding design control standards and