Advanced Manufacturing Engineer

5 days ago


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

**About the Role**

We are seeking a highly skilled Advanced Manufacturing Engineer to join our team at BRIOHEALTH SOLUTIONS INC. As a key member of our Operations team, you will work closely with cross-functional teams to design, develop, and implement manufacturing processes that meet our business needs.

Key Responsibilities

  • Design Transfer
    • Collaborate with R&D, Manufacturing Engineering, and Quality teams to transfer products to manufacturing.
    • Develop and implement manufacturing plans to ensure a robust design transfer from initial concept to full production.
    • Design and develop manufacturing processes, equipment, tooling, and fixtures to meet business requirements while enhancing process safety, quality, and productivity.
    • Support process validation activities, including development and execution of protocols and reports.
    • Lead and complete project teams in executing validation plans and protocols.
  • Process Support and Improvement
    • Investigate production issues and identify failure modes to improve production throughput and yields.
    • Develop and provide training materials and training for manufacturing personnel on newly developed processes.
  • Supplier Management
    • Build and maintain strong relationships with suppliers for manufacturing, materials, processes, and equipment.
  • Cross-functional Collaboration
    • Work closely with various departments, including R&D, Quality, Regulatory, and Manufacturing, to understand their needs.
  • Additional Responsibilities
    • Accept additional responsibilities as assigned by manager or senior Advanced Engineering personnel.
    • Identify technical risks, resource issues, and proposed solutions while building trust at all levels of the organization.
    • Assist in the 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 (e.g., 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.


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