R&D Engineer II – Cardiac Valve Systems

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 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