Anteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. We are currently developing a new class of TAVR designed to mimic the performance of a healthy aortic valve. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

We are currently seeking an entry-level, motivated Process Development Engineer I to join our Tissue Team in Maple Grove, MN. As a PD Engineer, you will play a vital role in the development and improvement of our medical devices' manufacturing processes.

Primary Duties and Responsibilities:

Process Development and Optimization

• Develop and optimize manufacturing processes for Class III medical devices, focusing on performance, quality, and efficiency.
• Implement and oversee the validation of IMV (Installation, Operational, Performance Qualification), TMV (Test Method Validation), IQ (Installation Qualification), OQ (Operational Qualification), and PPQ (Process Performance Qualification) activities.
• Drive continuous improvement initiatives to enhance product quality, reduce manufacturing costs, and increase productivity.
• Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to ensure seamless integration of new processes into production.
  
  
  

Jig Fixture Automation

• Design and develop automation solutions for jig fixtures to streamline manufacturing processes and reduce manual intervention.
• Oversee the implementation of automated processes, ensuring compliance with safety standards and regulatory requirements.
  
  
  

Validation and Documentation

• Prepare and execute validation protocols, including developing testing procedures, data analysis, and generating validation reports.
• Create and maintain comprehensive documentation, such as work instructions, standard operating procedures (SOPs), and process flowcharts, in accordance with regulatory guidelines and Good Manufacturing Practices (GMP).
  
  
  

GMP Compliance

• Ensure all processes and manufacturing activities adhere to Good Manufacturing Practices (GMP) and other relevant regulatory requirements.
• Collaborate with the Quality Assurance team to address any compliance issues and implement corrective actions.
  
  
  

Cross-Functional Collaboration

• Work closely with the R&D team to provide manufacturing inputs during product development, ensuring manufacturability and scalability of new designs.
• Collaborate with the Manufacturing team to transfer new processes into production and provide ongoing support for process-related issues.
  
  
  

Education, Skills and Knowledge:

• Requires a Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical, or related field).
• A minimum of one internship in Process Development, Manufacturing Engineering, or similar, within the medical device industry, preferably with Class III medical devices, is preferred. Research Assistant experience in a laboratory environment is also a plus.
• Specific experience with Transcatheter Aortic Valve Replacement (TAVR) or Transcatheter Mitral Valve Repair (TMVR) devices is a plus.
• An understanding of validation processes (IMV-TMV-IQ-OQ-PPQ) and documentation practices in a regulated environment is desired.
• Familiarity with jig fixture automation and process automation techniques.
• Understanding of Good Manufacturing Practices (GMP) and other relevant regulatory requirements.
• Excellent problem-solving skills and the ability to apply engineering principles to improve processes and solve technical challenges.
• Strong communication and interpersonal skills, with the ability to work effectively in cross-functional teams.
  
  
  

What We Offer:

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Inclusive, collaborative and dynamic work environment with a culture of innovation and excellence.
• Competitive compensation package including salary, performance-based bonuses, and RSUs.
• Career development opportunities and a chance to be part of a growing company that values its employees.
  
  
  

Health and Wellness Offerings:

• Bonus Plan Eligibility
• 401k + Company Match
• Paid Holidays & Vacation
• Medical, Dental, and Vision Plans
• Employee Equity Program (EEP)
• Flexible Spending Account (FSA)
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Employee Assistance Program
  
  
  

At Anteris Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.

Anteris Technologies recruits, employs, trains, compensates and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.