Medical Device Verification & Validation Engineer

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

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Medical Device V&V Engineer position right now. The detailed job description is as follows

Position: Medical Device Verification & Validation Engineer

Location: San Antonio, TX (100% Onsite)

Duration: 12+ Month Contract

Job Overview

We are seeking a Medical Device Verification & Validation Engineer to support new product development and sustaining engineering initiatives. The ideal candidate will have strong experience in mechanical verification and validation, protocol development, statistical analysis, and testing of sterile medical devices within a regulated environment.

Key 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.

Required 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 Design Verification & Validation 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.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala
Recruiting Manager
Stark Pharma Solutions Inc

Email: [e-mail]

15 Corporate Place S, Suite 350,
Piscataway, New Jersey 08854
www.starkpharma.com