- 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.
- Bachelor's degree in Mechanical Engineering, or a related field, with a minimum of 5 years' experience in medical device testing.
- 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.
- 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.
- 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.
- 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
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Senior Test Engineer - Osseo, United States - Anteris Tech
Description
Job Description
Job 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:
Required Degree and Experience:
Required Skills and Knowledge:
Preferred Skills:
What We Offer:
Health and Wellness Offerings:
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.
