Senior Engineer

6 days ago

Boston, Massachusetts, United States BRIOHEALTH SOLUTIONS INC Full time
Job Description

BrioHealth Solutions Inc. is seeking an experienced and driven Advanced Manufacturing Engineer to join our dynamic team. As an Advanced Manufacturing Engineer, you will play a pivotal role in the transfer of products and process technologies from R&D to Manufacturing ensuring safety, quality, and regulatory goals are met.

Key Responsibilities
  • Design Transfer:
    • As a member of the Operations team, you will work closely with R&D, Manufacturing Engineering and Quality to transfer products to manufacturing.
    • You will develop and implement manufacturing plans to accomplish a robust design transfer from initial concept to full production to support new products, product changes and enhancements.
    • You will design and develop manufacturing processes, associated equipment, tooling, and fixtures to meet business needs while enhancing process safety, quality, and productivity.
    • You will support all process validation activities (e.g., development and execution of PC/IQ/OQ/PQ)
    • Create and execute validation plans, protocols and reports.
    • As part of the project team, you will be responsible for helping to lead and completing the pFMEA process, DFM/DFA, risk analysis and process control strategies.
  • Process Support and Improvement:
    • In conjunction with Manufacturing Engineering and Quality investigate production issues, identify failure modes to improve production throughput and yields.
    • You must possess a broad understanding of current process technologies, bio/med device assembly methodologies, commercial fabrication techniques, creating and maintaining specialized environments, etc.
    • Provide training materials and training for manufacturing personnel for newly developed processes as needed.
  • Supplier Management:
    • Build and maintain strong relationships with suppliers for manufacturing, materials, processes and equipment. Identify alternative suppliers as needed.
  • Cross-functional Collaboration:
    • Apply persistence and determination in organizing, managing, and motivating, cross-functional teams to implement and integrate new process technologies to meet market and revenue requirements.
    • Work closely with various departments, including R&D, quality, regulatory and manufacturing, to understand their needs.
  • Other:
    • Accept additional responsibilities as assigned by manager or Senior Engineer.
    • Identify technical risks, resource issues and proposed solutions while continuing to build trust at all levels of the organization.
    • Development of intellectual property is required.
    Requirements
    • Bachelor's degree in manufacturing, Mechanical, Electrical Engineering or other engineering discipline.
    • Minimum of 2 years of experience in product or process development.
    • Medical device, pharmaceutical, and biotechnology work experience is highly preferred.
    • Experience in an FDA/ISO regulated environment (eq. ISO 9000, ISO 13485, FDA 21 CFR, EU MDR) is preferred.
    • Experience in quality compliance (DFM, DOE, continuous process improvement, SPC).
    • Excellent communication and interpersonal skills.
    • Proficiency in design software (SolidWorks) and tools.
    • Proficient in Microsoft Office 365 applications and tools.
    • Strong organizational skills and attention to detail.

About BrioHealth Solutions Inc.

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.

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