Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create lifechanging outcomes for patients. We are currently developing the first-in-class biomimetic TAVR valve as a growing and inclusive MedTech team with global office locations in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia.

Anteris is dedicated to advancing medical technologies that improve patient outcomes and enhance the quality of life for individuals with cardiovascular conditions. We are seeking a highly skilled and experienced Senior Test Engineer with a strong background in TAVR devices to join our dynamic and growing team.

As a Sr Test Engineer, you will play a crucial role in the development, testing, and validation of our TAVR devices. Your expertise in SolidWorks and Geometric Dimensioning and Tolerancing (GD&T) will be essential for designing and conducting tests, ensuring the highest standards of quality and compliance.

Primary Duties and Responsibilities:

• TAVR Device Testing: Plan, develop, and execute comprehensive test plans for our TAVR device- delivery system, primarily benchtop testing
• SolidWorks Design: Utilize SolidWorks and other engineering tools to design and develop test fixtures, prototypes, and components for TAVR device testing and validation.
• Validation and Verification Testing- Proven track record and hands-on experience in performing validation and verification testing and data analysis.
• Geometric Dimensioning and Tolerancing (GD&T): Apply GD&T principles to accurately define and communicate the tolerances and dimensions of TAVR device components and assemblies for testing and manufacturing purposes.
• Data Analysis: Analyze test results, identify trends, and provide detailed reports to the engineering team and management for decision-making and refinement of the device design.
• Compliance and Documentation: Ensure all testing processes, documentation, and reports comply with relevant regulatory standards, including FDA and ISO requirements.
• Collaboration: Work closely with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to ensure seamless integration of test processes throughout the product development lifecycle.
• Continuous Improvement: Continuously seek opportunities to optimize test methods, streamline processes, and improve overall efficiency to achieve project timelines and goals.
• Risk Management: Identify potential risks during the testing phase and collaborate with the team to implement appropriate mitigation strategies.
• Training and Mentorship: Provide guidance and mentorship to junior engineers and team members, contributing to their professional growth and development.
• Conduct testing in accordance with industry standards and regulatory requirements such as ISO 5840, ISO 10555, and FDA guidelines.

Required Degree and Experience:

• Bachelor's degree in Mechanical Engineering, or a related field, with a minimum of 5 years’ experience in medical device testing.

Required Skills and Knowledge:

• Proficiency in SolidWorks and other engineering software for 3D modeling and design.
• Familiarity with relevant FDA / ISO standards
• Strong knowledge of Geometric Dimensioning and Tolerancing (GD&T) principles.
• In-depth understanding of relevant industry standards, regulations, and best practices.
• Excellent problem-solving skills and the ability to think critically in complex engineering scenarios.
• Strong interpersonal and communication skills to collaborate effectively with multidisciplinary teams.
• Detail-oriented with a commitment to maintaining high-quality documentation.
• Experience with risk management methodologies in the context of medical device testing.
• Ability to work independently as well as contribute to a team environment.

Preferred Skills:

• Graduate degree in Mechanical Engineering or a related field
• Familiarity with cardiovascular devices, especially TAVR or other Structural Heart systems.
• Pre-clinical testing and simulation studies is a plus
• Previous experience with catheter-based medical devices and interventional cardiology procedures.
• Knowledge of statistical analysis tools and methodologies for test data evaluation.

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.
• Competitive compensation package, including salary, performance-based bonuses, and stock options.
• Career development opportunities and a chance to be part of a growing company that values its employees.

Health and Wellness Offerings:

• Medical, Dental, and Vision Offerings
• Flexible Spending Account (FSA)
• 401k Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Stock Option Plan
• Paid Holidays & Vacation
• Employee Assistance Program
• Inclusive Team Environment

At Anteris Technologies, we are committed to fostering a diverse and inclusive workplace that encourages innovation and creativity. We value teamwork, integrity, and the pursuit of excellence in everything we do. If you are a motivated individual with a passion for advancing medical technologies and improving patient outcomes, we encourage you to apply for this exciting opportunity as a Senior Test Engineer in our Maple Grove, MN, office.