Senior Manufacturing Engineer

Anteris Technologies•Brooklyn Park, MN

About The Position

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. We are seeking a Senior Manufacturing Engineer to provide technical leadership for delivery system manufacturing processes, supporting catheter-based systems for next-generation structural heart technologies. This role is responsible for ensuring that delivery system manufacturing operations are robust, scalable, validated and compliant as the organization advances toward clinical milestones and commercial readiness. This role will serve as the subject matter expert in catheter and delivery system manufacturing partnering closely with R&D, Quality, Regulatory, Supply Chain, Process Development, and Production. The role combines hands-on engineering support with process ownership, ensuring manufacturing processes meet the highest standards of quality, compliance, and operational performance. At Anteris Technologies, you’ll join a mission-driven team dedicated to improving the lives of patients with aortic stenosis through breakthrough structural heart technologies — and help build the organizational foundation supporting that impact.

Requirements

Bachelor’s degree in Mechanical, Biomedical, Industrial, or related Engineering discipline with 5+ years of experience in manufacturing engineering experience within medical devices or catheter-based delivery systems.
3+ years’ experience with a graduate degree.
Demonstrated experience supporting process validation in FDA-regulated environments
Experience with structured problem solving
Excellent cross-functional collaboration and communication
High attention to detail and commitment to quality and compliance

Nice To Haves

Direct experience with catheter-based devices strongly preferred.
Experience working in a pre-commercial or scaling organization.
Advanced degree (MS) in Engineering or related field.

Responsibilities

Establish and maintain the Device Master Record (DMR) for delivery system products including: specifications, BOM structures, manufacturing procedures, and production records.
Define and control Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) for: Catheter assembly and sub-assemblies, Balloon forming and bonding, Sheath assembly, adhesives, and leak testing
Conduct process capability analyses, GR&R studies, and statistical evaluations to ensure process robustness
Lead efforts to scale delivery system manufacturing from clinical builds to commercial production
Drive yield improvements, scrap reduction, and cycle time optimization
Develop, execute, and maintain validation activities including: Process, equipment, inspection, and test method validation (IQ/OQ/PQ/PPQ)
Own risk management documentation including PFMEA and control strategies
Partner with Quality and Regulatory to ensure alignment with: FDA Quality System Regulation (21 CFR 820), ISO 13485 and applicable global standards
Ensure validation packages and processes are inspection- and audit-ready
Provide hands-on engineering support for catheter and delivery system manufacturing operations
Troubleshoot process deviations, nonconformances, and CAPAs related to: Assembly, bonding, balloon forming, and system integration
Lead engineering investigations for manufacturing and quality issues
Own and drive change management activities for: Process improvements, Equipment updates, Documentation revisions
Develop and continuously improve SOPs, work instructions, and batch records
Specify, procure, and qualify: Delivery system manufacturing equipment, tooling, and fixtures
Define calibration and preventative maintenance strategies
Design and optimize fixtures, tooling, and workstations to improve: Repeatability, Operator efficiency, Ergonomics
Partner with R&D and Process Development during design transfer to ensure manufacturability
Support internal and external audits, including FDA and notified body inspections
Provide technical input to regulatory submissions and validation documentation
Interface with suppliers of delivery system components and materials to ensure: Quality, Process compatibility
Lead continuous improvement initiatives using Lean and Six Sigma methodologies
Implement data-driven monitoring systems to track and improve process performance
Mentor junior engineers and technical staff, supporting development of manufacturing capabilities