Anteris Technologies

Process Development Engineer II

Brooklyn Park, MN · Mid

Sponsorship not specifiedDetected 22 days ago

Data AnalysisGMPMedical DevicesCollaboration

About the role

With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.
Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function.

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.
Design and develop automation solutions and jig fixtures to streamline manufacturing processes and reduce manual intervention.
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).
Collaborate with the Quality Assurance team to address any compliance issues and implement corrective actions.
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.

Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical, or related).
Knowledge and experience in validation processes (IMV-TMV-IQ-OQ-PPQ) and documentation practices in a regulated environment.

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care.

Develop and optimize manufacturing processes for medical devices, focusing on performance, quality, efficiency. and compliance with regulatory standards.

This listing is sourced directly from Anteris Technologies's careers page and normalized into a canonical job model.