R&D Engineer II

Anteris Technologies; Brooklyn Park (MN); On-site; USD 95,000 - 115,000; Full time

Benefits offered by this job

Stock options

401k + Company Match

Bonus plan eligibility

Paid holidays & vacation

Employee equity program

Job summary

Anteris Technologies in Minneapolis, MN is seeking an R&D Engineer II to support systems design, development, and early-stage validation of Class III medical devices. You will translate user needs and clinical requirements into robust product designs, and collaborate across Marketing, Clinical, Process Development, Quality, Regulatory, and Manufacturing to ensure scalable and compliant solutions.

This hands-on role requires independent execution of core design activities, with emphasis on risk

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, or related).
• 2-5 years of experience in medical device R&D or product development.
• Experience in a regulated environment (Class III preferred).

Responsibilities

• Contribute to the design and development of a system of heart valve and catheter-based delivery tools and components.
• Generate design concepts, prototypes, and engineering solutions aligned to product requirements.
• Support development builds, feasibility testing, and iterative design improvements.
• Translate clinical, user, and system requirements into engineering specifications.
• Design and execute bench testing, characterization, and verification activities.
• Support development of test methods and fixtures for device evaluation.
• Analyze data to evaluate performance, identify failure modes, and guide design decisions.
• Document results in technical reports and contribute to design history files.
• Work with Marketing and Clinical to capture and translate customer needs into system requirements.
• Partner with valve and delivery tool design teams to ensure robust systems are delivered.
• Partner with Process Development to ensure system designs are manufacturable and scalable.
• Collaborate with Quality to support risk management, testing strategies, and documentation.
• Collaborate with Regulatory to ensure all standards are met and system is submission ready.
• Work with Manufacturing and Supply Chain to support design transfer activities.
• Contribute to risk analysis activities (FMEA) and support design controls per FDA/ISO.

Skills

Bachelor's degree in Engineering

2-5 years R&D experience

Experience in regulated environment

Education

Bachelor's degree in Engineering

Tools

CAD

Prototyping tools

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.

Anteris is seeking a R&D Engineer II who will be responsible for supporting the Systems design, development, and early-stage validation of innovative Class III medical devices. This role contributes to translating user needs and clinical requirements into robust product designs, collaborates cross-functionally to advance products from concept through design verification, validation, and transfer.

This is a hands-on engineering role where you will independently execute core design activities while partnering closely with Marketing, Clinical, Process Development, Quality, Regulatory, and Manufacturing to ensure designs are scalable, compliant, and aligned with customer needs and system requirements.

Main Responsibilities

Design & Product Development:

• Contribute to the design and development of a system of heart valve and catheter-based delivery tools and associated components
• Generate design concepts, prototypes, and engineering solutions aligned to product requirements
• Support development builds, feasibility testing, and iterative design improvements
• Translate clinical, user, and system requirements into engineering specifications

Testing & Design Verification

• Design and execute bench testing, characterization, and verification activities
• Support the development of test methods and fixtures for device evaluation
• Analyze data to evaluate performance, identify failure modes, and guide design decisions
• Document results in technical reports and contribute to design history files

Cross-Functional Collaboration

• Work with Marketing and Clinical to capture and translate customer needs into system requirements
• Partner with valve and delivery tool design teams to ensure robust systems are delivered
• Partner with Process Development to ensure system designs are manufacturable and scalable
• Collaborate with Quality to support risk management, testing strategies, and documentation
• Collaborate with Regulatory to ensure all standards are met and system is submission ready
• Work with Manufacturing and Supply Chain to support design transfer activities

Risk Management & Documentation

• Contribute to risk analysis activities (FMEA)
• Support design controls in accordance with FDA and ISO standards
• Participate in design reviews and ensure proper documentation within DHF

Continuous Improvement & Problem Solving

• Investigate technical challenges using structured problem-solving methods
• Support root cause analysis and corrective actions during deployment
• Identify opportunities to improve product performance, reliability, and usability

Required Qualifications

Skills, Knowledge, Experience & Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, or related)
• 2-5 years of experience in medical device R&D or product development
• Experience working in a regulated environment (Class III preferred)

Preferred Qualifications

• Familiarity with structural heart therapies (TAVR, TMVR highly desirable)
• Experience with design controls, verification/validation, and risk management
• Proficiency with CAD and prototyping tools
• Experience developing test methods and analyzing engineering data

Compensation

Target base salary range: $95,000 – $115,000, plus eligibility for an annual short-term incentive (STI) targeted at 7% 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.
• 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

This is the national market pay scale.

Salary Range

$95,000 - $115,000 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.