Design Quality Engineer

About Us

We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enabling chronic MCS therapy to be accessible to more patients across the globe.

Job Summary

BrioHealth Solutions Inc. is seeking a Design Quality Engineer to support QA compliance activities for an active implantable medical device. This exempt-level role is critical in ensuring the quality, safety, and regulatory compliance of our medical devices throughout the design and development lifecycle.

As a Design Quality Engineer, you will lead and oversee quality engineering principles, design control processes, and risk management strategies to drive the success of our innovative products. Your expertise will help ensure that our devices meet industry standards, regulatory requirements, and internal quality objectives from concept to manufacturing.

Responsibilities

Design Control & Compliance

• Ensure adherence to design control processes across the entire product development lifecycle, including planning, design inputs / outputs, verification, validation, and transfer to manufacturing.
• Develop and maintain comprehensive design control documentation, including design plans, risk management files, and verification / validation reports.
• Conduct and facilitate design reviews to assess compliance with regulatory standards, industry best practices, and internal quality procedures.
• Apply risk management methodologies (ISO 14971) to identify, evaluate, and mitigate risks associated with medical device design and usage.

Risk Management & Quality Assurance

Supplier & Regulatory Support

Qualifications