B.E./B.Tech in Mechanical Engineering with 4+ years of experience
Experience in cross-functional collaboration on Medical Device systems
Proficiency in design verification and validation testing
Skilled in creating and executing test protocols
Experienced in data analysis using Minitab and other statistical tools
Knowledge in product stability and shelf-life testing for sterile products
Familiarity with GR&R studies and test method development is a plus
Responsibilities
Participate in all phases of new product development to grasp design intent
Plan and execute verification protocols, analyze results, and maintain the Design History File
Conduct functional, performance, and packaging testing
Collaborate with global teams to ensure verification methods are compliant and aligned
Demonstrate understanding of measurement systems and testing standards
Interpret design verification data concerning product performance
Manage multiple projects while prioritizing tasks effectively
Benefits
Opportunity to work in the innovative medical device industry
Gain experience in cross-functional team dynamics
Exposure to regulatory standards and compliance practices
Involvement in product design and development lifecycle
Access to advanced statistical analysis tools
Full Job Description
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.
