R&D Engineer II

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

Skills, Knowledge, Experience & Qualifications

Required 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