Senior Process Development Engineer

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.

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.

The Sr PD Engineer will be a key member of the manufacturing development and support team partnering with management, Quality Assurance, R&D / Product Development, and Production functions. This is a multi-faceted role with the Engineer responsible for assisting in several critical areas including:

• Test method development and validation
• Process and product characterization
• Equipment validation & calibration set-up and requirements
• Conducting feasibility studies and pilot programs for new process technologies.
• Identifying and implementing new technologies and methodologies to improve existing processes

The person shall execute duties to meet cGMP requirements on time and to the highest quality standards to ensure that programs are compliant with regulatory requirements and related site SOPs. This role will have a heavy emphasis on biological tissue, production, performance, and characterization.

Primary Duties and Responsibilities

1. 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.
• Comfortable performing root cause analysis using standard industry techniques (5 Whys, Fishbone, etc).
• Lead risk management activities in compliance with ISO 14971 and FDA 21 CFR Part 820, ensuring comprehensive hazard analysis, failure mode assessments, and risk mitigation throughout the product lifecycle
• Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to ensure seamless integration of new processes into production.

1. 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.

1. 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).

1. 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.
• Strong track record of maintaining compliance with global regulatory standards including ISO 13485

1. 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.
• Lead cross-functional discussions and engage with external manufacturers or test facilities to expand team/company technologies.

Skills, Knowledge, Experience & Qualifications

• Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical) or related scientific field. Graduate degree a plus.
• Minimum of 5 - 8 years' experience in Process Development and Manufacturing Engineering within the medical device industry, preferably with Class III medical devices.
• Experience completing cleaning validations is highly beneficial, particularly experience developing protocols, executing studies, and interpreting results.
• Comfortable with performing protocol drafting, execution, data analysis, and report generation with minimal oversite.
• Capable of working independently on validation activities including protocol drafting, execution, data analysis, and report generation with minimal oversite.
• Specific experience with tissue-integrated Transcatheter Aortic Valve Replacement (TAVR) or Transcatheter Mitral Valve Repair (TMVR) devices is highly desirable.
• Work experience on manufacturing processes utilizing biological materials for integration into combination products is beneficial
• 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.
• 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.
• 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 Plans
• 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

Note: We may require proof of COVID-19 vaccination to comply with the state, local municipality, and/or travel regulations.

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.