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Senior Test Engineer

4 months ago

Osseo, United States Anteris Tech Full time
Job DescriptionJob DescriptionSalary:

 

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.