Sr. Quality Engineer

At BrioHealth Solutions, we push the limits of what technology can do to improve lives for patients suffering from advanced heart failure by challenging ourselves and each other to make tomorrow better than yesterday. We need fresh ideas and inclusive insights to continue to be a leading medical technology innovator. We strive to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients.

This onsite position is based in Billerica, MA and requires up to 15% travel.

Responsibilities may include the following, and other duties may also be assigned.

• Production Quality:

• Provides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis.
• Leads the incoming, in-process and final inspection activities and associated processes for the Billerica facility.
• Establishes and maintains quality assurance processes to ensure compliance with applicable regulations and standards, such as ISO 13485, FDA QSR, and other relevant guidelines.
• Conducts the Material Review Board (MRB) meetings for the Billerica facility; identifies compliance gaps, conducts root cause analysis and corrective actions for non-conforming components.
• Ensures that product quality meets applicable requirements and device history records are complete prior to product lot release.
• Initiates and executes Engineering Change Orders (ECOs) for areas of responsibility.
• Adheres and promotes adherence to established procedures.

• Design Transfer:

• Works closely with R&D, Design Quality and Manufacturing Engineering to transfer products to manufacturing.
• Supports the operations team with developing and implementing manufacturing plans to accomplish a robust design transfer from initial concept to full production for new products, product changes and enhancements.
• Supports the operations team with designing and developing manufacturing processes, associated equipment, tooling, and fixtures to meet business needs while enhancing process safety, quality, and productivity.
• Collaborates with the operations team to incorporate risk management principles into the process design and facilitate risk-based decision making.
• Assists the operations team with conducting process design and risk reviews to assess compliance with regulatory requirements, industry standards, and internal quality procedures.
• Plays a key role in drafting and finalizing pFMEA, DFM/DFA, and process control strategies.
• Assists with creation, execution and completion of all process validation activities (e.g., process development and execution of IQ/OQ/PQ).

• Process Support and Improvement:

• Provides support to the operations team in troubleshooting, implementing production throughput and yield improvements, training on new products or processes, verifying documentation compliance.
• Supports creation of training materials and execution of training for manufacturing personnel for newly developed processes as needed.
• Reviews and helps maintain Manufacturing Procedures, Test Procedures, Calibration Procedures, and Quality Control Procedures and Instructions.

• Supplier Management:

• Assists the supply chain team with building and maintaining strong relationships with suppliers for manufacturing, materials, processes and equipment.
• Assists with identification and qualification of alternative suppliers, as needed.
• Assists manufacturing engineering and supply chain teams with implementing supply chain sustaining and cost reduction activities.
• Collaborates with suppliers to ensure their processes and products meet the necessary quality standards and regulatory requirements.
• Participates in supplier audits and assessments, addressing any identified non-conformances or quality issues.
• Supports supplier qualification and selection processes by evaluating their quality systems, capabilities, and performance.

• Cross-functional Collaboration:

• Applies persistence and determination in organizing, managing, and motivating, cross-functional teams to implement and integrate new process technologies to help improve product quality.
• Works closely with various departments, including R&D, manufacturing, supply chain, and regulatory affairs, to understand and address their needs.

• Other:

• Identifies technical risks, resource issues and proposed solutions while continuing to build trust at all levels of the organization.
• Collaborates with cross-functional teams to ensure adherence to design control processes throughout the product development lifecycle, including planning, design inputs, design outputs, verification, validation, and transfer to manufacturing.
• Applies risk management methodologies, such as ISO 14971, to identify, evaluate, and mitigate risks associated with the manufacturing process and use of medical devices.
• Conducts process audits and assessments to verify compliance with manufacturing procedures and quality management system requirements.
• Performs statistical analysis and trending of quality data to identify areas for improvement and implement corrective and preventive actions (CAPAs).
• Participates in internal audits and assessments.
• Assists in the preparation and submission of regulatory filings, such as Investigational Device Exemptions (IDE), Pre-Market Approvals (PMA), 510(k) submissions, technical files, and design dossiers.
• Supports regulatory inspections and audits, addressing any findings and implementing appropriate corrective actions.
• Stays updated with relevant regulations, guidelines, and industry best practices pertaining to medical device design, development, and quality assurance.

To be considered for this role, please ensure the minimum requirements and your permanent address are evident on your resume.

• Bachlor’s degree in Engineering or related field (mechanical, biomedical, electrical)
• Proficient with dimensional inspection and test equipment.
• Minimum of 5 years of relevant production quality / manufacturing engineering experience within the medical device industry.

• Advanced Engineering degree
• Production quality / manufacturing engineering experience with Class III active implantables/life-support medical devices.
• ASQ Quality Engineer certification.
• DMAIC Lean / Six Sigma Certification and demonstrated experience leading DMAIC projects.
• Strong understanding of design control processes, risk management principles, and quality management systems
• Familiarity with relevant regulatory requirements and standards, such as FDA regulations, ISO 13485, EU MDR, and ISO 14971.
• Highly results oriented and focused on business priorities
• Strong leadership and influencing skills to drive results in a highly matrixed organization.
• Strong understanding of process validation.
• Proficient in applying statistical methods and tools for data analysis and quality improvements.
• Excellent communication/presentation skills.
• Excellent interpersonal skills.

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 enable chronic MCS therapy to be accessible to more patients across the globe.