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Manufacturing Engineer

2 months 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 a key member of our Operations team, 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.

Responsibilities
  • Design Transfer:
    • Collaborate with R&D, Manufacturing Engineering, and Quality to transfer products to manufacturing.
    • 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.
    • Design and develop manufacturing processes, associated equipment, tooling, and fixtures to meet business needs while enhancing process safety, quality, and productivity.
    • Support all process validation activities, including development and execution of PC/IQ/OQ/PQ.
    • Create and execute validation plans, protocols, and reports.
    • Lead and complete the pFMEA process, DFM/DFA, risk analysis, and process control strategies as part of the project team.
  • Process Support and Improvement:
    • Investigate production issues, identify failure modes, and improve production throughput and yields in conjunction with Manufacturing Engineering and Quality.
    • Possess a broad understanding of current process technologies, bio/med device assembly methodologies, commercial fabrication techniques, and creating and maintaining specialized environments.
    • 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.
    • Develop intellectual property.
    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 (e.g., 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.