Mechanical Test Engineer 3-7Yrs

• Author, Execute, perform, summarize, report out verification & validation test activities of components to a full system device: Which includes but not limited to:

• Test Plans, Test Procedures, User and Functional Requirements testing,
• Design Verification,
• Installation/Operational/Performance Qualification Protocols,
• Support compliance/ closure of Regulatory and Quality requirements before completing Design Outputs/ Program Deliverables.
• Support the qualification of lab area, productivity improvement efforts, including testing, building fixtures, calibration and data collection.
• Diagnose, isolate and investigate problem reports. Drive product improvements.
• Works with external test houses (such as XXX) to define the test scope, author the test plans, test procedures, execute & consolidate the reports.
• Ensure good documentation and Good Manufacturing practices are followed in the Verification and Validation Process
• Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives
• Participate in V&V development process improvement and test automation.
• Maintains awareness of current regulatory trends and their impact on the Verification and validation status of equipment and processes.
• Support the SMEs on Regulatory responses and Audits, as needed
• Adheres to client's Quality Management system & supports the quality audits.
• Presents the findings / objective evidence and able to present with rationale with applicability / exclusions

• Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed.

• Bachelor's degree in mechanical engineering or related field
• 3 to 7 years of experience in Verification and validation testing of Mechanical hardware and System.
• Relevant technical testing/reliability experience in electro-mechanical testing
• An understanding of test methods and processes as well as the methods used to verify products in the realms of mechanical, electrical, functional and environmental testing environments.
• Experience in - writing system, subsystem-level and module level verification and validation plans, procedures, Test Execution and Test report generation
• Understanding of hardware product design methodologies and test practices.
• Familiarity with reliability theory and analysis as it pertains to test quantities derived from reliability.
• Experience in medical device or similar product development, design verification/validation, system integration (involving software & hardware), risk management, reliability engineering, process validation and Quality systems
• Deep domain knowledge in design verification and validation of medical devices is a plus.
• Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards.
• Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously
• Self-motivated with good interpersonal skills.

Rangam Infotech