Work Flexibility: Hybrid or Onsite

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.

Who we want:

• 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

Must-Have Requirements

• 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

​Nice to have Requirements

• 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

 

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