Test Engineer interacts with other engineering groups to define, document, analyze, perform, and interpret tests for products, systems, components, or modifications. Identifies functional problems and suggests resolutions. Being a Test Engineer assists in the definition of internal quality control standards and the maintenance of reliability programs. Documents and analyzes test cases and provides regular progress reports. Additionally, Test Engineer ensures testing procedures are in compliance with any required industry specific standards. Requires a bachelor's degree of Engineering. Typically reports to a supervisor or manager. The Test Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Test Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Description:
We are seeking a skilled and motivated Test Engineer II to join our Research and Development team. As a Test Engineer II, you will be responsible for planning, designing, executing, and analyzing tests to assess the performance and safety of our delivery system and associated accessories. Your work will directly contribute to the successful development and regulatory approval of our products.
Test Planning and Design:
- Collaborate with cross-functional teams to understand product requirements and objectives.
- Develop comprehensive test plans, strategies, and protocols to validate the performance, durability, and safety of the TAVR system.
- Work on Test method justifications for clinical relevance.
- Create and maintain test documentation, including test cases, procedures, and specifications.
Test Execution:
- Perform a wide range of tests, including functional, performance, reliability, and safety tests, on prototypes and final products.
- Conduct testing in accordance with industry standards and regulatory requirements, such as ISO 5840, ISO 10555, and FDA guidelines.
- Utilize mechanical and material testing methods using high precision equipment and data collection software tools.
- Collect and record test data accurately and ensure traceability of results.
Data Analysis and Reporting:
- Analyze test results to identify issues, anomalies, or deviations from design specifications.
- Prepare detailed test reports with clear and concise summaries of findings, conclusions, and recommendations.
- Collaborate with engineering teams to implement corrective actions based on test results.
Equipment and Tool Management:
- Maintain and calibrate test equipment and instrumentation to ensure accuracy and reliability.
- Maintain test environment and lab space – as needed.
- Recommend and procure new equipment as needed to support testing requirements.
Regulatory Compliance:
- Collaborate with R&D team to ensure all testing activities are conducted in compliance with relevant regulatory standards and requirements.
Continuous Improvement:
- Identify opportunities for process improvements in testing methodologies, equipment, and procedures.
- Participate in design reviews and contribute to product development enhancements.
Top Skills Details:
Additional Skills & Qualifications:
- Bachelors 2 years OR Masters 1 year/internship
- Experience with SolidWorks and GD&T; experience using statistical software like Minitab.
- Experience with design verification planning, testing and reports.
- Strong understanding of mechanical engineering principles and methodologies.
- Experience creating technical, written content.
- Demonstrated data analytical skills.
- Experience with early feasibility testing and submissions.
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
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