The Principal Process Development Engineer is a senior technical leader within the Manufacturing Development and Support team. This role partners closely with Quality Assurance, R&D/Product Development, and Manufacturing to develop, characterize, validate, and scale critical processes supporting Anteris Technologies’ transcatheter heart valve platform.

This position requires deep expertise in catheter-based device manufacturing and process validation, with responsibility for advancing manufacturing readiness from development through commercialization. The Principal Process Development Engineer will lead complex validation activities, drive process capability improvements, and serve as a technical mentor to junior engineers. This role plays a central part in ensuring the reliability, scalability, and performance of manufacturing processes supporting Anteris Technologies’ structural heart innovations.

At Anteris® Technologies, you’ll join a team committed to improving the lives of patients with aortic stenosis through groundbreaking structural heart solutions. This is an opportunity to make a measurable impact on patient outcomes while shaping the future of heart valve innovation.

Primary Duties and Responsibilities

Process Development and Optimization

• Lead the development, characterization, and optimization of manufacturing processes for Class III catheter-based medical devices.
• Translate design intent into scalable, robust manufacturing processes capable of supporting clinical and commercial production.
• Conduct feasibility studies and pilot programs for new process technologies and manufacturing approaches.
• Drive process characterization activities supporting transition to validated production processes.
• Implement mistake-proofing strategies and process improvements to reduce variability and human error in assembly operations.
• Identify opportunities for mechanization and automation of catheter assembly processes to improve efficiency and scalability.

Process Validation

• Lead the development and execution of comprehensive validation strategies including pFMEA, process characterization, and validation studies.
• Develop and execute protocols including IQ, IMV/TMV, OQ, and PQ/PPQ.
• Author and review validation protocols, technical reports, and study documentation.
• Contribute to development and execution of Master Validation Plans.
• Ensure validation activities meet cGMP requirements, regulatory standards, and internal quality system procedures.

Manufacturing & Continuous Improvement

• Support the transfer of processes from R&D to Manufacturing with focus on yield, throughput, and reproducibility.
• Drive root cause investigations and corrective/preventative actions for process deviations or performance issues.
• Lead initiatives to improve manufacturing efficiency, product quality, and cost structure.
• Develop and maintain manufacturing documentation including procedures, work instructions, and technical reports.
• Participate in internal and external audits as required.

Equipment & Calibration

• Support definition and validation of equipment requirements for new manufacturing processes.
• Assist with development of calibration requirements for critical instruments, sensors, and production equipment.
• Support calibration schedules and documentation in alignment with site quality requirements.

Technical Leadership & Mentorship

• Provide technical guidance and mentorship to Process Development Engineers.
• Support development of engineering best practices within the manufacturing development organization.
• Contribute to technical problem solving across development and production teams.

Cross-Functional Collaboration

• Partner with R&D, QA/QC, and Manufacturing teams to support product and process development programs.
• Support design verification testing and design control activities as needed.
• Contribute technical expertise to risk assessments and product development initiatives.
• Evaluate and implement emerging technologies that improve manufacturing performance.

Skills, Knowledge, Experience & Qualifications

Required Qualifications

• Bachelor’s degree in in Engineering or related disciplines.
• Minimum 10 years of experience in process development and validation within regulated medical device manufacturing.
• At least 5 years of experience supporting Class II medical device development programs.
• Extensive experience with catheter manufacturing processes, including:
  • braided shaft forming
  • adhesive jointing
  • laser bonding or welding
  • balloon forming
  • catheter assembly processes
• Proven experience executing full validation lifecycle including:
  • IQ
  • IMV/TMV
  • OQ
  • PQ/PPQ
• Demonstrated expertise translating pFMEA and product specifications into process development and validation strategies.
• Strong background in process characterization, DOE, and statistical analysis.
• Experience leading root cause investigations and implementing corrective actions.
• Proven success driving continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.
• Strong technical writing skills including protocol development and validation reporting.
• Excellent cross-functional collaboration and communication skills.

Preferred Qualifications

• Advanced degree in Engineering or related discipline.
• Experience contributing to Master Validation Plan development and execution.
• Experience designing jigs, fixtures, and automation solutions for medical device assembly.
• Experience supporting commercialization-scale manufacturing.
• Demonstrated ability to mentor and develop junior engineers.

Compensation:

Target base salary range: $150,000 – $170,000, plus eligibility for an annual short-term incentive (STI) targeted at 10% 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