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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