Senior Process Development Engineer

We are seeking a Senior Process Development Engineer to lead the development, validation, and commercialization readiness of manufacturing processes supporting our transcatheter heart valve system and associated delivery components.  This role is responsible for translating design intent into robust, scalable, and compliant manufacturing processes suitable for pivotal clinical and commercial production. The position partners closely with R&D, Quality, Regulatory, Supply Chain, and Manufacturing to ensure process capability, documentation integrity, and regulatory readiness.  This is a hands-on, technically deep role with strategic impact as we scale toward commercialization.

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

Process Development & Commercialization Readiness

• Plan and execute development and optimization of manufacturing processes for Class III transcatheter heart valves.
• Drive process characterization, improvements, and capability studies to establish robust and commercial-ready valve manufacturing processes.
• Provide DFM/DFA input during product development to ensure manufacturability and cost efficiency.
• Support global manufacturing alignment as processes are standardized and scaled.

Process Validation & Regulatory Execution

• Author and execute validation strategies, including IQ, OQ, PQ/PPQ, TMV, IMV and equipment qualifications in alignment with the Master Validation Plan and applicable regulatory requirements (FDA, ISO 13485, and EU MDR).
• Ensure robustness of the validation packages meeting industry requirements for auditability and regulatory compliance. are audit-ready and inspection-ready.
• Partner with R&D, Quality and Regulatory during process developments, regulatory submissions and periodic inspections.
• Support risk management activities including PFMEA and control plan development.

Process Development

• Evaluate and implement emerging technologies for semi-automated and automated solutions for fixture design, assembly processes, and test methods, including establishing equipment specification, and vendor selection.
• Improve repeatability and reduce operator variability through fixture optimization and automation strategies.
• Evaluate and implement bioburden solutions for valve manufacturing, ensuring effectiveness and process compatibility.  
• Improve and establish visual inspection methods for tissue and valve manufacturing, ensuring repeatability and reproducibility.
• Plan and execute product performance and functional assessments associated with process changes and improvements.

Design Transfer & Manufacturing Support     

• Drive design transfer activities from R&D to Manufacturing.
• Develop manufacturing documentation including SOPs, work instructions, process flows, and training materials.
• Provide on-floor technical support for complex builds, process deviations, and yield improvements.
• Investigate nonconformances and drive root cause analysis and CAPA execution.

Continuous Improvement & Cost Optimization

• Identify opportunities to improve yield, reduce scraps, and enhance cycle time.
• Lead structured problem-solving initiatives using data-driven methodologies.
• Support cost-of-goods reduction initiatives while maintaining compliance and product performance.

General

• Follow the Anteris Quality Management System and comply with all applicable procedures and training requirements.

Skills, Knowledge, Experience & Qualifications

Required Qualifications:

• Bachelor’s degree in Mechanical, Biomedical, Industrial, or related Engineering discipline with 5+ years of experience in Process Development or Manufacturing Engineering within Class III medical devices.  3+ years’ experience with a graduate degree.
• Demonstrated experience executing IQ/OQ/PQ/PPQ and Test/ Inspection Method Validation in a regulated environment.
• Experience with design transfer from development into regulated production.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and EU MDR expectations.
• Hands-on experience with fixture design, process automation, and equipment qualification.
• Proven ability to lead cross-functional initiatives and influence without direct authority.
• Proficient in technical documentation and verbal communication.
• Ability to use microscopes and other magnification equipment

Preferred Qualifications:

• Degrees in Engineering or Chemical Engineering and/or an advanced degree (MS) in Engineering or related field desired.
• Direct experience with catheter-based or structural heart devices strongly preferred.
• Experience with transcatheter heart valves (TAVR, TMVR, TPV) or delivery systems.
• Experience working in a pre-commercial or scaling organization.
• Background in Class III medical devices
• Knowledge of ISO 5840-1/ -3.

Compensation

Target base salary range: $118,000 – $138,000, plus annual incentive opportunity and equity eligibility.  Final compensation will be 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 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
• Inclusive Team Environment