Principal Process Development Engineer

Anteris Technologies; Brooklyn Park (MN); Sur place; USD 150 000 - 170 000; Plein temps

Avantages offerts par ce poste

Medical, Dental and Vision plans

Flexible Spending Account (FSA)

401k + Company Match

Life, AD&D, Short/Long Disability

Bonus Plan Eligibility

Employee Equity Program

Paid Holidays & Vacation

Employee Assistance Program

Résumé du poste

Anteris Technologies seeks a Principal Process Development Engineer to lead development, validation, and optimization of manufacturing processes for our transcatheter heart valve platform. You will partner with QA, R&D, and Manufacturing to scale processes from development to commercialization.

The role requires deep expertise in catheter-based device manufacturing, executing full validation lifecycles, and mentoring junior engineers to advance manufacturing readiness and performance.

Qualifications

• Bachelor’s degree in Engineering or related field.
• Minimum 10 years in process development and validation within regulated medical device manufacturing.
• At least 5 years supporting Class II medical device development programs.
• Experience with catheter manufacturing processes and validation lifecycle (IQ/OQ/PQ).
• Strong technical writing and cross-functional collaboration skills.

Responsabilités

• Lead development, characterization, and optimization of manufacturing processes for Class III catheter-based medical devices.
• Translate design intent into scalable, robust processes for clinical and commercial production.
• Drive validation strategies including pFMEA, IQ, IMV/TMV, OQ, PQ/PPQ.
• Develop Master Validation Plans and validation documentation.
• Support transfer of processes from R&D to Manufacturing focusing on yield and reproducibility.
• Lead root-cause investigations and continuous improvement initiatives.
• Provide mentorship to junior engineers and contribute to best practices.

Connaissances

Process development

Validation

Catheter manufacturing

DOE

Statistical analysis

Lean Six Sigma

Technical writing

Cross-functional collaboration

Mentorship

Root cause analysis

Formation

Bachelor’s degree in Engineering

Advanced degree (preferred)

Outils

Master Validation Plan

Jigs and fixtures design

Description du poste

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world’s first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti-calcification technology, is designed to mimic the natural function of a healthy heart valve.

ThePrincipal 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 at10% 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

This is the national market pay scale.

Salary Range

$150,000 - $170,000 USD

Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.

Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Anteris Technologies’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.