Senior R&D Test Technician

2 weeks ago

Maple Grove, United States Anteris Tech Full time
Job DescriptionJob DescriptionSalary:

Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing 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.  Help us build a team that will shape the future of TAVR.

 

The Senior R&D Test Technician at Anteris is responsible for maintaining and running multiple test procedures and protocols that meet regulated quality standards along the product development process and life cycle. This individual will provide the required technical support and detail as they monitor, assemble, improve, and proactively manage device testing in a cross-functional team environment.

 

This individual will show attention to detail and exhibit a structured and versatile problem-solving approach. They will be adept at setting priorities, following test procedures and protocols, and contributing to test development and lab capability and capacity planning while maintaining good laboratory and documentation practice to ensure compliance.


Primary Duties and Responsibilities:


  • Technical testing related to product functionality assessment which includes concept feasibility, design verification and sustaining engineering with an emphasis on new product development.
  • Active participant in the development and review of testing methods and standard operating procedures.
  • Support project teams in planning and delivering test work.
  • Produce high quality test data and, interpret and present findings to the project team and clients.
  • Prepare technical documentation, e.g. test methods, test protocols and reports with reference to all appropriate medical device regulations and standards.
  • Support change through training and adoption of best practices.
  • Report results of all unexpected results and plan related testing investigations and nonconformance assessments.
  • Drive completion of all experiments, planning and executive analysis
  • Support equipment validation preventive maintenance and repair activities as needed.
  • Liaise with 3rd party suppliers.
  • Conduct onboarding and training for other technicians as required.
  • Maintain good documentation processes and audits.
  • Socially inclusive to the unique needs of a diverse global team


Required skills, knowledge, experience & qualifications:


  • High School diploma or GED required.
  • Minimum of 5 years of direct laboratory experience in a Medical Device R&D testing or diagnostics laboratory.
  • Structured and methodical problem-solving approach.
  • Track record in developing complex or novel testing methodologies.
  • Extensive experience writing detailed protocols and performing high quality test work.
  • Proficiency in the use of data analysis tools and statistical analysis (ideally Minitab).
  • Versatility to work diligently and effectively as part of several projects.
  • Attention to detail.


Preferred skills, knowledge, experience & qualifications:


  • Bachelor of Science degree desired.  Graduate degree a plus.
  • Knowledge and experience developing and executing test methodologies for assessing the safety and efficacy of medical devices.
  • Detailed understanding of industry standards and regulations for medical device testing (ideally the ISO-5840 series).
  • Working knowledge of quality management systems (ideally Grand Avenue).
  • Excellent communication, business acumen and presentation skills to technical and non-technical audiences, including external stakeholders.
  • Ability to work with a high degree of integrity across a diverse, multi-cultural team with various time zones.


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.

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