Manufacturing Engineer 2

Help get Anteris’ heart valve technology from the production floor to clinical sites. As a Manufacturing Engineer II, you’ll own the production processes for packaging and labeling, from setting up manufacturing lines to making sure approved product configurations are reflected in our manufacturing systems. You’ll work directly with Production, Quality, Regulatory, R&D, and Supply Chain to solve problems on the floor, put engineering changes into practice, and keep clinical shipments on schedule while meeting cGMP and quality system requirements.  You’ll also help shape how Anteris manufactures at commercial scale. From designing fixtures that make work easier for operators to setting up new lines and qualifying equipment and processes, you’ll help build the capacity Anteris needs as manufacturing expands.

 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 needs while maintaining compliance with established manufacturing and quality system requirements.
• Understand packaging validation principles and applicable requirements to assess the impact of packaging changes, and provide appropriate engineering justification.
• Support commercial production scalability during site transfers and manufacturing expansion, including capacity planning, production line setup, equipment implementation, and equipment/process qualification.
• Design and develop manufacturing fixtures and tooling to improve process consistency, ergonomics, efficiency, and manufacturability.
• Apply 5S, standard work, and Lean and Six Sigma principles to improve workflow, reduce waste, and support scalable manufacturing operations.
• Ensure compliance with Anteris Quality System and applicable SOPs.
• Demonstrate strong attention to detail to identify procedural gaps, documentation inconsistencies and opportunities for process improvement.
• Support NCMRs, CAPAs, including root cause investigation, implementation of corrective actions, and effectiveness verification.
• Demonstrate accountability for delivering assigned work on time and provide clear, timely updates on progress, priorities, risks, and challenges to management and cross-functional stakeholders.

Skills, Knowledge, Experience & Qualifications:

Required Qualifications

• Bachelor of Science degree with 2+ years of relevant experience, Master of Science degree with 1+ year of relevant experience, or an equivalent combination of education and experience in medical device manufacturing.
• Proficiency in 3D CAD using SolidWorks and working knowledge of Microsoft Office.
• Experience developing labels and barcodes to GS1 standards using BarTender, LABELVIEW, Easylabel, or similar software.
• Strong analytical and troubleshooting skills, including the ability to identify root causes and recommend solutions.
• Strong technical writing and review skills, with close attention to detail and the ability to explain technical findings and recommendations clearly in Material Review Board (MRB) and cross-functional discussions.
• Ability to work independently, manage multiple priorities, follow through on commitments, and keep teammates and stakeholders informed of progress and issues.

Preferred Qualifications

• Degree in Packaging Engineering.
• At least one year of experience in product packaging and labeling is strongly preferred.
• Knowledge of statistics, quality systems, and applicable regulatory requirements.

Note:

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

Salary Range 90000 - 110000 USD