Test Engineer Ii (Contract)

Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. With global office locations in Minneapolis, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we are at the forefront of developing the first-in-class biomimetic Transcatheter Aortic Valve Replacement (TAVR) valve, which promises to revolutionize cardiovascular care. Join us in our mission to make a meaningful impact on the healthcare industry.

We are seeking a skilled and motivated Test Engineer II to join our Research and Development team as a long-term contractor (through the end of 2024, with the possibility of going full time in 2025). As a Test Engineer II, you will play a pivotal role in ensuring the quality and reliability of our groundbreaking TAVR valve and system. 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.

Key Responsibilities:

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.

Basic Qualifications:

• Bachelor's degree in Engineering with a minimum of 3 years’ experience as a Hardware Test Engineer in a medical device or healthcare-related industry. A master’s degree with 1-2 years' experience is a plus.
• 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.
• Working knowledge of Microsoft Office suite.
• Demonstrated written and verbal communication skills.
• Experience creating technical, written content.
• Demonstrated data analytical skills.
• Experience with early feasibility testing and submissions.

Preferred Qualifications:

• Ability to manage multiple tasks and projects.
• Ability to interpret technical drawings and create bill of materials.
• Strong communication, presentation, technical writing, and organizational skills.
• Experience with component qualifications, including using external manufacturers to build custom components.
• Experience in management of test equipment calibration.
• Knowledge of standards and directives such as ISO 5840.
• Prior experience developing Class III medical devices.
• Experience in product design and development in an R&D environment.
• Familiarity with manufacturing processes, quality assurance, reliability assurance, clinical, and risk management.

What We Offer:

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Collaborative and dynamic work environment with a culture of innovation and excellence.
• A chance to be part of a growing company that values its employees.

Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.

Anteris Technologies recruits, employs, trains, compensates and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.

Job Type: Contract

Pay: $55.00 - $65.00 per hour

Expected hours: 40 per week

Experience level:

• 2 years
• 3 years
• 4 years
• 5 years

Schedule:

• 8 hour shift

Ability to Relocate:

• Maple Grove, MN: Relocate before starting work (Required)

Work Location: In person