Job Description

Job Summary

The Mechanical Test Engineer in the V&V team within Specialty Monitoring should be with proven expertise in testing medical products that combine both hardware and software. The person will work with other members of V&V and other teams (system engineering, mechanical designer) etc. to ensure that the hardware subsystem and the system is thoroughly verified and documented according to quality management system. The successful candidate will possess solid “hands-on” technical abilities, demonstrate excitement and energy for product quality, and a passion for their work and the impact it has on meeting the needs of patients.

Essential Duties and Responsibilities

• 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.

Qualifications & Personality Traits

• 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.