| Job Description: |
Must Have Technical/Functional Skills
· Medical Device industry experience.
· Strong experience in protocol writing, execution, and report generation.
· Hands-on experience in Verification & Validation (V&V) activities.
· IT systems experience.
· Exposure to legacy operating systems, particularly Windows 2000.
· Ability to work with legacy technologies and systems.
· Knowledge of regulated environments and quality processes.
· Strong analytical and problem-solving skills.
· Excellent written and verbal communication skills.
· Self-motivated and able to work with minimal supervision.
· Familiarity with FDA, ISO 13485, and IEC 62304 standards is a plus.
Roles & Responsibilities
We are looking for a senior-level Verification & Validation (V&V) Engineer with experience in the Medical
Device industry. The ideal candidate will be responsible for protocol development, execution, and
reporting while working independently in a regulated environment.
Key Responsibilities
· Develop, review, and execute V&V protocols and test plans.
· Prepare validation reports and ensure accurate documentation of results.
· Perform protocol execution and document observations, deviations, and outcomes.
· Support verification and validation activities throughout the product lifecycle.
· Collaborate with cross-functional teams including Engineering, Quality, and Regulatory Affairs.
· Work with legacy systems and technologies as required.
· Ensure compliance with applicable quality and regulatory requirements
Role Descriptions: "Key ResponsibilitiesDevelop| review| and execute V&V protocols and test plans.Prepare validation reports and ensure accurate documentation of results.Perform protocol execution and document observations| deviations| and outcomes.Support verification and validation activities throughout the product lifecycle.Collaborate with cross-functional teams including Engineering| Quality| and Regulatory Affairs.Work with legacy systems and technologies as required.Ensure compliance with applicable quality and regulatory requirements."
Essential Skills: Senior V&V Engineer
Desirable Skills:
Keyword:
Skills: ISO 13485~EIS : Medical Device & Regulations
Experience Required: 8-10 |
