We are seeking a Senior Process Development Engineer who will be a key member of the Manufacturing Development and Support team, partnering closely with Management, Quality Assurance, R&D/Product Development, and Production. This is a technically deep and multi-faceted role responsible for developing, validating, and optimizing manufacturing processes supporting Class III structural heart devices.

The Engineer will contribute across several critical areas including process and product characterization, test method development and validation, equipment validation and calibration requirements, feasibility studies for new process technologies, and the implementation of improved manufacturing methodologies. This individual will execute all activities in accordance with cGMP requirements, regulatory expectations, and site SOPs to ensure processes are robust, compliant, and scalable. The role has a strong emphasis on biological tissue processing, device production, performance characterization, and process reliability.

At Anteris Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.

Primary Duties and Responsibilities

Process Development and Optimization

• Develop and optimize manufacturing processes for medical devices, with focus on performance, quality, scalability, and efficiency.
• Lead process characterization activities and transition processes through OQ readiness and commercialization.
• Drive continuous improvement initiatives to enhance product quality, reduce manufacturing cost, and increase manufacturing throughput.
• Apply structured problem-solving methodologies such as 5 Whys, Fishbone, and statistical analysis to resolve process issues.
• Lead risk management activities in accordance with ISO 14971 and FDA 21 CFR Part 820, including hazard analysis, failure mode assessment, and risk mitigation throughout the product lifecycle.
• Partner with cross-functional teams including R&D, Quality, and Manufacturing to ensure seamless integration of new processes into production environments.
• Conduct feasibility studies and pilot programs to evaluate and implement new process technologies and manufacturing methods.

Catheter Manufacturing & Process Expertise

• Support development and optimization of processes related to catheter or sheath manufacturing, including assembly, adhesive joining, thermal bonding, and reflow processing.
• Implement mistake-proofing strategies (poka-yoke) and automation approaches to improve assembly reliability and reduce human error.
• Drive mechanization and automation initiatives to improve process consistency, throughput, and manufacturability of catheter-based devices.

Jig Fixture Automation

• Design and implement automation solutions and jig fixtures to streamline manufacturing processes and reduce manual intervention.
• Oversee implementation of automated processes ensuring compliance with safety standards and regulatory requirements.

Validation and Documentation

• Lead validation activities including IMV, TMV, IQ, OQ, and PPQ, including protocol development, execution, data analysis, and report generation.
• Develop robust validation strategies and technical documentation aligned with regulatory expectations.
• Prepare validation protocols, testing procedures, and validation reports demonstrating process capability and compliance.
• Create and maintain documentation including SOPs, work instructions, validation reports, and process flow documentation in accordance with GMP requirements.

GMP Compliance

• Ensure manufacturing processes comply with Good Manufacturing Practices (GMP) and applicable global regulatory requirements.
• Partner with Quality Assurance to address compliance issues and implement corrective and preventive actions.
• Maintain strong adherence to ISO 13485 quality system requirements and related documentation practices.

Cross-Functional Collaboration

• Provide manufacturing input during product development, ensuring design decisions support manufacturability and scalability.
• Collaborate with Manufacturing to support technology transfer and process scale-up into production.
• Lead cross-functional technical discussions and coordinate with external manufacturers or test facilities when needed to advance company technologies.

Skills, Knowledge, Experience & Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Industrial Engineering, or related scientific field; advanced degree preferred.
• 5+ years of experience in Process Development and Validation within the medical device industry, preferably with Class II medical devices.
• Demonstrated expertise in catheter or sheath manufacturing processes, including assembly, adhesive joining, thermal bonding, and reflow processing.
• Strong experience in process characterization and transition to OQ, including assembly mistake-proofing and root cause resolution.
• Proven track record executing validation activities (IQ, IMV/TMV, OQ, PQ) including protocol creation, execution, and report writing.
• Experience preparing technical reports, validation reports, and engineering studies in a regulated environment.
• Experience with cleaning validation development and execution is highly beneficial.
• Familiarity with automation techniques and jig fixture design in manufacturing environments.
• Experience working with biological materials or tissue-based medical device products is highly desirable.
• Strong knowledge of GMP, ISO 13485, FDA Quality System Regulations, and validation documentation practices.
• Excellent analytical, troubleshooting, and problem-solving abilities.
• Strong communication skills and the ability to collaborate effectively across cross-functional teams.

Compensation:

Target base salary range: $120,000 – $135,000, 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