Senior Test Engineer – Instruments & Accessories
SAN CARLOS, CA
The successful Senior Test Engineer candidate will lead V&V activities for multiple instrument and accessories projects including single use catheter-based products and ancillary items used as part of a robotically controlled system. He/she will lead test development and documentation for novel robotically manipulated medical instruments and accessories. These products will include articulating endoscopes and associated accessories. The Senior Test Engineer will own the Master Validation Plan, Test Protocol Development and Trace Matrix throughout the V&V stage from pre-V&V engineering test development to Final Test Report release as part of the formal design documentation package and 510k submission. As expected in a start-up environment, the successful Senior Test Engineer candidate will have the capacity and curiosity to participate in multiple other product development related activities as needed for the success of the team.
- Lead test method development and associated test fixture/measurement tooling design, documentation, procurement, and qualification.
- Actively participate and document product and component testing of intricate mechanisms, mechanical assemblies and components used in disposable medical devices and supporting instruments & capital equipment.
- Participate in the development and documentation of specifications, test methods and protocols to ensure the functionality, safety and efficacy of medical devices in accordance with medical device regulations.
- Lead assessments and explore solutions for failed test protocols, as well as solving challenging design problems at the component level and system level via inspection, testing, analysis, and experimentation.
- Creates and maintains Testing Documentation including Master Validation Plan (MVP), Test Protocols, Specification Trace Matrix, Test Reports and Summaries.
- Creates and maintains SolidWorks CAD models and detailed drawings for test fixtures and custom measurement tooling.
- Contributes in the transfer of design documentation, specifications and test methods for production release.Leads and participates in the generation and execution of protocols for verification and validation testing, along with reports.
- Participates in technical design reviews presenting test plans, strategies & schedules as well as open issues for each product development stage.
- Utilizes critical thinking and state of the art principles in the test development, statistical modeling and risk assessment.
- Uses Design For Manufacturing and Assembly (DFMA) principles in test fixture design and development.
- Works collaboratively and effectively in a small start-up environment, contributing in many areas with minimal supervision.
- Senior Test Engineer will be based on previous, successful experience in similar roles in the medical device arena and demonstration of representative capabilities
- Experience with Verification & Validation in the development of medical devices including: disposable accessories, articulating catheters, endoscopes, and/or surgical instruments.
- Experience in successfully developing and executing MVPs for single use medical devices.
- Previous experience with successful V&V execution for single use medical device
- Experience with Process Validation for: assembly processes, machining, sheet metal, injection molding, polymer extrusions, EDM, laser cutting, rapid prototyping, and cable assemblies.
- Demonstrated strength and recent experience using statistical methods including calculation of reliability for critical product requirements relative to the necessary confidence level.
- Demonstrated ability & successful experience working with cross functional teams.
- S. degree required in Mechanical, Biomedical, or related Engineering discipline.
- Proven proficiency and experience in SolidWorks CAD system.