Senior Manufacturing Engineer

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.

Primary Duties and Responsibilities

Delivery System Manufacturing Process Ownership

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

Process Validation & Compliance

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

Manufacturing Support and Technical Leadership

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

Equipment and Manufacturing Infrastructure

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

Cross-Functional and Regulatory Support

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

Continuous Improvement & Team Development

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

Skills, Knowledge, Experience & Qualifications

Required 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

Preferred Qualifications:

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.

Compensation:

Target base salary range: $113,000 – $133,000, plus eligibility for an annual short-term incentive (STI) targeted at 8.5% of base salary and equity participation. Final compensation will be determined based on experience and alignment with role requirements. Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

What We Offer:

Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.

Inclusive Team Environment - 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 Equity Program

Paid Holidays & Vacation

Employee Assistance Program

This is the national market pay scale.

Salary Range $113,000 — $133,000 USD

Note: We may require proof of COVID-19 vaccination to comply with health institutions, 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.