Process Development Engineer II

3 weeks ago

Maple Grove, United States Anteris Technologies Ltd Full time

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.

Anteris Technologies is currently seeking a skilled and motivated Process Development Engineer II to join our dynamic 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. Join us and contribute to the advancement of cutting-edge medical devices, particularly in the field of Transcatheter Heart Valve interventions.

Main Responsibilities:

Process Development and Optimization:

    • Develop and optimize manufacturing processes for Class III medical devices, focusing on performance, quality, and efficiency.
    • Conduct manufacturing process qualification activities, including manufacturing inspection method and test method validation, IQ, OQ, PQ/ PPQ to ensure processes meet product specifications and regulatory requirements.
    • Optimize, trouble shoot and drive continuous improvement initiatives to improve product quality, yield, cost effectiveness, and increase productivity while maintaining compliance with quality standards.
    • Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to ensure seamless integration of new processes into production.
Jig / Fixture Development and Automation:
    • Design and develop manufacturing jigs/ fixture and automation solutions to standardize, streamline manufacturing processes and reduce manual intervention.
    • Oversee the implementation of automated processes, ensuring compliance with safety standards and regulatory requirements.
Documentation and Compliance:
    • 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).
    • 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.
Risk Management and Problem Solving
    • Utilize tools such as Failure Mode Effects Analysis (FMEA) and root cause analysis to identify and mitigate potential risks in the process.
Cross-Functional Collaboration:
    • Collaborate with R&D team to understand design requirements and provide manufacturing inputs during early stages of product development, ensuring manufacturability and scalability of new designs.
    • Partner with Quality Assurance to ensure all processes are compliance with FDA, ISO 13485, and other relevant standards.
    • Collaborate with the Manufacturing Operation team to transfer new processes into full-scale production and provide ongoing support for process-related issues.
Required Skills and Knowledge:
  • Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical, or related field).
  • Minimum of 2 years of experience in Process Development and Manufacturing Engineering within the medical device industry, preferably with Class III medical devices.
Preferred Skills and Knowledge:
  • Specific experience with Transcatheter Aortic Valve Replacement (TAVR) or Transcatheter Mitral Valve Repair (TMVR) devices is highly desirable.
  • Strong knowledge and experience in validation processes (IMV-TMV-IQ-OQ-PPQ) and documentation practices in a regulated environment.
  • Familiarity with jig/ fixture automation and process automation techniques.
  • Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, ISO 14971 and ISO 5840.
  • 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 written, communication and interpersonal skills, with the ability to work effectively in cross-functional team environment
  • Attention to detail, organized, and able to manage multiple projects simultaneously.
  • Proven ability to thrive in a fast-paced, dynamic environment with frequent changes in priorities.
Please note that experience with TAVR or TMVR devices is highly valued due to their complexity and specific manufacturing requirements. Candidates with this experience will be given priority consideration during the selection process.

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

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