Senior Principal Test Engineer
Our client is a leader in innovative technologies that addresses the unmet needs in cardiovascular diseases. They have an opportunity for a Senior Principal Test Engineer.
In this role you will provide supply chain and test engineering expertise for all products for new product development and operations.
- Identify the strategic direction for automated test platforms to ensure re-usability, scalability, favorable cost, and favorable test times
- Define and manage projects related to development of automated test platforms
- Develop and maintain test platforms (both hardware and software) intended for design verification and production test
- Develop test specifications, schematics, protocols, and reports for design verification and production test
- Plan, perform, coordinate, and/or oversee design verification testing and reporting
- Analyze test results to pro-actively identify issues and optimize yield for design verification and production test
- Implement root cause analysis, corrective and preventive actions to resolve product and test issues, including purchased parts
- Coordinate and/or perform failure analysis and troubleshooting of prototypes, products, and equipment
- Provide statistical analysis and sample size inputs to production and development qualification/validation testing and data
- Plan, perform, or assist with Gage R&R studies of equipment
- Pro-actively identify and implement new sources for electronic parts suppliers
- Participate or lead supplier audits of electronic parts suppliers
- Maintain relationships with electronic assembly contract manufacturers
- Provide engineering support of production as assigned
- Develop and maintain non-product software and firmware
- BS Degree in electrical engineering, computer science or software engineering or technical equivalent plus 15 years or more experience in a medical device company.
- Previous experience as an engineer in verification activities, verification systems and production test systems in the medical device environment
- Previous experience as an engineer in supply chain engineering activites in a medical device environment
- Knowledge of FDA QSR and ISO 13485 regulatory requirements, guidelines and standards that pertain to medical devices
- Knowledge of additional international regulations, radio equipment regulations, and risk management and cybersecurity standards - A Plus!
- Class III implantable medical device experience. Active implantables experience - A plus!
- Ability to interface with internal and external customers in all aspects of the product life cycle
- Ability to apply statistics to solve problems and determine sampling plans
- Previous experience with risk and hazard analysis
- Ability to provide work direction to other technical employees and consultants
- Skills to be successful – analytical, communication and interpersonal skills, organizational, problem solving, project management
- Previous experience using six sigma tools – Preferred!
Keywords: test engineer, engineering, engineer, medical device, software engineer, computer science, automated test platforms, hardware
"By applying to this position, you are confirming that you understand the requirements needed for this position, and further confirm that you possess the necessary skills and requirements, as outlined above".