Advanced Manufacturing Engineer

2 weeks ago

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

Advanced Manufacturing Engineer I

Job DescriptionBrioHealth Solutions Inc., 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. Your expertise will contribute to the organization's operational efficiency and overall success.Responsibilities
  • Design Transfer:
    1. As a member of the Operations team, you will work closely with R&D, Manufacturing Engineering and Quality to transfer products to manufacturing.
    2. 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.
    3. You will develop manufacturing processes, associated equipment, tooling, and fixtures to meet business needs while enhancing process safety, quality, and productivity.
    4. You will support all process validation activities (e.g., development and execution of PC/IQ/OQ/PQ)
    5. Execute validation plans, protocols and reports.
    6. 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:
    1. In conjunction with Manufacturing Engineering and Quality investigate production issues, identify failure modes to improve production throughput and yields.
    2. Provide training materials and training for manufacturing personnel for newly developed processes as needed.

  • Supplier Management:
    1. 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:
    1. Accept additional responsibilities as assigned by manager or senior Advanced Engineering personnel.
    2. Identify technical risks, resource issues and proposed solutions while continuing to build trust at all levels of the organization.
    3. Assist in development of intellectual property.

Requirements
  • Bachelor’s degree in manufacturing, Mechanical, Electrical Engineering or other engineering discipline.
  • 1- 4 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) is preferred.
  • 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

BrioHealth Solutions Inc., Inc. is an advanced medical device company dedicated to the research, development, and commercialization of a miniaturized implantable ventricular assist system (CH-VAD®) featuring total magnetic suspension (TMS) for the treatment of end-stage chronic heart failure. With offices in the U.S. and China, we are growing our U.S. team in preparation for clinical studies and regulatory approval in the U.S. and Europe.

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