Staff R&D Test Engineer(Hybrid)
Position Summary
This role leads the development, evaluation, and validation of various test methods to verify the functionality of the next-generation guidewire. This position requires the engineer to demonstrate leadership and provide guidance to cross-functional teams regarding test system capabilities, performance, and processes. The successful candidate must excel in a high-energy, small-focused team environment, be able to recognize and drive continuous improvement projects and have a commitment to high product quality. This position requires a quick learner and demonstrates the ability to work in a cross-functional environment. An excellent sense of shared responsibility and shared reward is required, as is the ability to make work fun and interesting.
- Analytical problem solvers: People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- Dedicated achievers: People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Curious learners: People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.
- Goal-oriented engineers: Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
- Effective communicators: People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
What you will do
- Drive the creation of test engineering strategy along with the design & process team; develop, align & execute test methods needed to bring new products to market
- Perform analyses on functional tests, close test gaps, and develop debug lists,
- Use statistical analyses of manufacturing test results to establish appropriate pass/fail criteria and to evaluate test system performance
- To drive root cause of failures from system test and functional tests.
- Maintain BOM for test fixtures, spares, hardware, software, and PC configurations
- Transfer Functional test fixtures from contract manufacturers and support them with change implementations, training, maintenance, and debug
- Drive projects within the Test Engineering group and/or with cross-functional teams focused on process and equipment automation for production at large
- Design, develop, and maintain automated test scripts and frameworks to support product verification and validation.
- Identify opportunities for automation within existing testing processes and recommend solutions.
- Ensure that automated test methods comply with regulatory standards and quality requirements.
- Provide technical expertise and guidance on test automation best practices to cross-functional teams.
What you need
- BS degree in Electrical, Mechanical, or Biomedical Engineering or equivalent
- Minimum 4+ years of experience in applications development, embedded system, manufacturing engineering, test engineering, diagnostics software
- Experience with Medical Design Control processes
- Candidate must be of high character and energy with a high regard for detail
- "Self-starter" attitude and comfort in a hands-on environment, where they can demonstrate an ability to work with other engineers, technicians and contract manufacturers
- Experience in basic analog and digital design, mechanical design, software design, and statistics
- Excellent documentation skills and ability to communicate effectively both verbally and written across all levels of the organization
- Mindset for Continuous Improvement and the ability to recognize and drive those opportunities
- A real excitement to learn and get to the bottom of problems
- Prior experience with Documentation and production control systems: Agile, SAP, Valgenesis
- Experience in test engineering in a medical device company or other regulated business
- Knowledge of Measurement Traceability and Gage R&R