Process Development Engineer II

Requirements

• 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.

Benefits

Additional Information

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team. Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world's first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti-calcification technology, is designed to mimic the natural function of a healthy heart valve. Anteris is seeking a Process Development Engineer II to join our dynamic team in Brooklyn Park, MN. As a PD Engineer, you will play a vital role in the development and improvement of our medical devices' manufacturing processes. The ideal candidate should possess a Bachelor's degree and have a minimum of 2 years of experience working with Class II or Class III medical devices. Help us build a team that will shape the future of TAVR. Main Responsibilities: Process Development and Optimization: Develop and optimize manufacturing processes for medical devices, focusing on performance, quality, efficiency. and compliance with regulatory standards. Create and implement manufacturing process IMV (Inspection Method Validation), 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 through data analysis, root cause analysis, and the implementation of corrective actions. 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 and 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. Conduct risk assessments and contribute to risk management activities related to the manufacturing process. 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. Basic Requirements: Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical, or related). Minimum of 2 years of experience in Process Development and Manufacturing Engineering within the medical device industry. Knowledge and experience in validation processes (IMV-TMV-IQ-OQ-PPQ) and documentation practices in a regulated environment.

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