Medical Device V&V Engineer: NPD & Compliance Focus

Stark Pharma Solutions Inc; San Antonio (TX); On-site; USD 110,000 - 150,000; Full time

Job summary

Stark Pharma Solutions Inc. seeks a Medical Device Verification & Validation Engineer for 12+ month contract in San Antonio, TX.

The ideal candidate will lead DV&V activities for new product development and sustaining engineering, ensuring compliance with FDA design controls and industry standards. Requirements include a Mechanical Engineering degree and 4+ years of Medical Device DV&V experience, with hands-on protocol development, Minitab stats, and stability testing.

Qualifications

• Bachelor's degree in Mechanical Engineering or related discipline.
• 4+ years of Verification & Validation experience within the Medical Device industry.
• Hands-on experience with DV&V activities, including protocol development, execution, and reporting.
• Strong experience using Minitab or other statistical analysis software.
• Knowledge of product stability testing and shelf-life validation for sterile medical devices.
• Experience working on new product development (NPD) and cross-functional engineering teams.

Responsibilities

• Support cross-functional teams throughout new product development and sustaining engineering activities.
• Develop, execute, and document Design Verification & Validation (V&V) protocols and reports.
• Perform functional, performance, packaging, and reliability testing for medical devices.
• Analyze test data using Minitab and other statistical tools to support product verification.
• Conduct product stability and shelf-life testing for sterile medical devices.
• Own V&V documentation within the Design History File (DHF).
• Ensure compliance with design controls, FDA regulations, and applicable industry standards.
• Collaborate with global engineering, quality, and operations teams to standardize verification methods and testing procedures.
• Manage multiple projects while supporting timely product development milestones.

Skills

DV&V

Protocol development

Statistical analysis

Cross-functional teams

Test planning

Education

Bachelor's degree in Mechanical Engineering

Tools

Minitab

Job description

Stark Pharma Solutions Inc. seeks a Medical Device Verification & Validation Engineer for 12+ month contract in San Antonio, TX.

The ideal candidate will lead DV&V activities for new product development and sustaining engineering, ensuring compliance with FDA design controls and industry standards. Requirements include a Mechanical Engineering degree and 4+ years of Medical Device DV&V experience, with hands-on protocol development, Minitab stats, and stability testing.