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 inc…
Skills: Process Development, Process Validation, Catheter Manufacturing, IQ/OQ/PQ, GMP Compliance
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 inc…
Skills: Process Development, Manufacturing Engineering, Validation (IQ/OQ/PQ), GMP Compliance, Root Cause Analysis
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 inc…
Skills: Process Validation, Catheter Manufacturing, PFMEA, Lean Six Sigma, Statistical Analysis
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 inc…
Skills: Office Management, EH&S Coordination, Purchasing, Logistics Support, Administrative Support
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 inc…
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 inc…
Skills: Equipment Maintenance, Fixture And Tooling Development, IQ OQ PQ, Data Collection, Technical Documentation
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 inc…
Skills: Regulatory Submissions, FDA Compliance, PMA Authoring, IDE Authoring, 510(k) Submissions
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 inc…
Skills: IT Infrastructure Management, IT Operations, Service Desk Management, ITIL, Cloud Infrastructure
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 inc…
Skills: Design Assurance, Risk Management, Design Controls, FDA 21 CFR 820, ISO 13485
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 inc…
Skills: Process Validation, Risk Management, Nonconformance Handling, FDA CFR 820, ISO 13485
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 inc…
Skills: Sustaining Engineering, Root Cause Analysis, CAPA, Design Control, Verification and Validation
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 inc…
Skills: Catheter System Design, Medical Device Development, Class III Implantable Devices, Structural Heart Technology, CAD Modeling
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 inc…
Skills: Raw Material Handling, GMP, ISO 13485, Laboratory Techniques, Cleanroom Operations
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 inc…
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 inc…
Skills: Clinical Trial Design, Protocol Development, Data Analysis, Medical Writing, Subject Selection
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 inc…
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 inc…
Skills: Medical Device Manufacturing, Tissue Processing, Cleanroom Operations, Inspection, Sterilization
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 inc…
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 inc…
Skills: Scheduling, Production Coordination, Customer Support, ERP Systems, Operations Administration
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 inc…
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$120k–$135k/yr
Full-time
bachelor degree, postgraduate degree
Medical Insurance, Dental Insurance, Vision Insurance, Flexible Spending Account (FSA), 401k With Company Match, Life Insurance
Posted 1d ago
~40 hrs/week
Responsibilities
Develop, validate, and optimize manufacturing processes for Class III structural heart devices, focusing on scalability and efficiency. Lead validation activities (IQ/OQ/PQ) and implement automation solutions to improve catheter manufacturing reliability.
Requirements
Requires a Bachelor's degree in Engineering or a related field with 5+ years of experience in medical device process development. Expertise in catheter manufacturing, GMP compliance, and validation protocols is essential.
Full job description
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.
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
This is the national market pay scale.
Salary Range
$120,000—$135,000 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.
Anteris® Technologies is a global healthcare company dedicated to revolutionizing cardiac care.
Industry
Medical Equipment Manufacturing
Company size
51-200 employees
Founded
2006
Headquarters
Eagan, MN
LinkedIn followers
11,511
Total funding
$354M
Anteris® Technologies is a global healthcare company dedicated to revolutionizing cardiac care. 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 sought 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.
Offices: 860 Blue Gentian Road, Suite 340, Eagan, MN 55121, US · 26 Harris Road, Malaga, Western Australia 6090, AU · Route de Pré-Bois, Genève, Geneva 1215, CH
Anteris® Technologies is a global healthcare company dedicated to revolutionizing cardiac care.
Industry
Medical Equipment Manufacturing
Company size
51-200 employees
Founded
2006
Headquarters
Eagan, MN
LinkedIn followers
11,511
Total funding
$354M
Anteris® Technologies is a global healthcare company dedicated to revolutionizing cardiac care. 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 sought 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.
Offices: 860 Blue Gentian Road, Suite 340, Eagan, MN 55121, US · 26 Harris Road, Malaga, Western Australia 6090, AU · Route de Pré-Bois, Genève, Geneva 1215, CH