Senior Manufacturing Engineer

About the role

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. Our mission is to pioneer science-driven and measurable advancements to restore heart valve patients to healthy function by creating the world's first biomimetic TAVR valve, DurAVR® THV.

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, and 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, and 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 and 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.

Qualifications

• 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.

Benefits

Competitive compensation package, including salary, performance-based bonuses, and stock options. Final compensation will be determined based on experience and alignment with role requirements. 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 Equity Program, Paid Holidays & Vacation, Employee Assistance Program. Salary Range: $113,000 - $133,000 USD.