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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Anteris Technologies by 2x