Manufacturing Engineer II

The posting, as Anteris Technologies wrote it

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.

The Manufacturing Engineer II will be a key member of the manufacturing engineering team, partnering with Management, Quality Assurance, Product Development, Supply Chain/ Logistics and Production. This role is responsible for executing manufacturing engineering activities in compliance with cGMP requirements, applicable regulatory standards, and site procedures, while ensuring deliverables are completed on time and to a high standard of quality.

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 Responsibilities

• Serve as the Manufacturing Process SME for product packaging and labeling, with ownership of production line setup, packaging configuration, labeling process, MRP setup, and manufacturing readiness to support on-time shipment of clinical products.
• Provide day-to-day production support to help ensure staff remain engaged, on task, and consistently adhere to GMP and established manufacturing procedures.
• Develop, maintain, and continuously improve manufacturing documentation, including manufacturing procedures, travelers/ device history records, BOMs, work instructions, and product specifications.
• Own and maintain the applicable process risk documentation and participate in risk analysis as needed.
• Co-own and maintain more than 50 packaging and labeling specifications and their associated manufacturing procedures, ensuring alignment with approved product configurations and labeling requirements.
• Partner closely with Supply Chain, Logistics, Quality, Regulatory, R&D, and Production to support production and clinical shipment schedules.
• Lead and support engineering changes related to packaging and labeling, including process improvement, documentation updates, product configuration changes, and implementation of corrective actions.
• Respond effectively to changing priorities and urgent field or clinical shipment

[…]
ient in 3D CAD (SolidWorks)

• Labeling and barcode development (GS1) using Bartender, Labelview, Easylabel or similar tools

Compensation

Target base salary range: $90,000 - $110,000, plus eligibility for an annual short-term incentive (STI) targeted at 7% 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.
• 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 Offerings
• Healthcare & Flexible Spending Account (HSA / 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
• Inclusive Team Environment

This is the national market pay scale.

Salary Range
$90,000 — $110,000 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.