Role Overview:This role is for a Mechanical Verification and Validation (V&V) Engineer, working with cross-functional teams on Medical Device systems with exposure to new product design and development. The position involves performing design verification and validation testing, including the creation and execution of test protocols, performing data analyses using MINITAB and other statistical software, and possessing knowledge and experience in product stability testing and shelf life of sterile medical products.
Key Responsibilities:- Participate in all phases of new product development & sustaining engineering to understand design intent, intended uses and relevant regulatory standards.
- Plan, create and execute verification protocols, reports, analyze and summarize results, enable formal design verification reviews and own the verification and validation portion of Design History File.
- Understand the product functionality and perform the Functional, Performance and Packaging testing for the product.
- Demonstrate initiative and engage global teams in operations, NPD/sustaining engineering to help and ensure that verification methods, protocols, procedures are harmonized, compliant and aligned.
- Complete understanding of standards, various equipment, tools gauges and measurement system.
- Interpret and analyze design verification data not only with product performance but with operational stability.
- Follow design control for medical devices and ensure compliance with all local state, federal, international and internal safety regulations, policies and procedures.
- Execute concurrently multiple projects and manage priorities.
Required Skills:- Working with cross functional team on Medical Device systems with exposure to new product design and development.
- Experience in performing design verification and validation testing including creation and execution of test protocols, performing data analyses using MINITAB and other statistical software.
- Knowledge and experience in product stability testing and shelf life of sterile medical products.
Qualifications:- B.E/B.Tech in Mechanical engineering.
- More than 4 years of relevant experience.
Preferred Skills:- Prior experience in GR&R study and test method development.
