What are the responsibilities and job description for the Design Quality Engineer position at BrioHealth Solutions?
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
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
- Lead risk assessment activities, including developing and maintaining risk management files, risk analyses, and risk control plans.
- Collaborate with engineering teams to integrate risk management principles into the design process and facilitate risk-based decision-making.
- Establish and maintain quality assurance processes to ensure compliance with ISO 13485, FDA QSR, and other applicable regulations.
- Conduct internal audits and assessments to verify compliance with quality management system requirements.
- Perform statistical analysis and trend monitoring of quality data to identify improvement areas and implement corrective and preventive actions (CAPAs).
- Supplier & Regulatory Support
- Collaborate with suppliers to ensure their processes and products meet required quality standards and regulatory expectations.
- Participate in supplier audits and assessments, addressing any non-conformances or quality concerns.
- Support supplier qualification and selection by evaluating their quality systems, capabilities, and performance.
- Stay up to date with regulations, guidelines, and industry best practices in medical device design, development, and quality assurance.
- Assist in preparing and submitting regulatory filings, including Investigational Device Exemptions (IDE), Pre-Market Approvals (PMA), 510(k) submissions, technical files, and design dossiers.
- Support regulatory inspections and audits, addressing any findings and implementing necessary corrective actions.
- Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related field); an advanced degree is a plus.
- 7 years of experience in the medical device industry, with a focus on design quality engineering or related roles.
- Strong knowledge of design control processes, risk management principles, and quality management systems (ISO 13485, FDA QSR).
- Familiarity with medical device regulatory standards, including FDA regulations, ISO 13485, EU MDR, and ISO 14971.
- Proficiency in applying statistical methods and tools for data analysis and quality improvement.
- Excellent problem-solving skills, with the ability to make data-driven decisions.
- Strong communication and collaboration skills, with the ability to work cross-functionally.
