Senior Manufacturing Engineer

2 weeks ago


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

As a key member of the Operations team at BRIOHEALTH SOLUTIONS INC, you will play a vital role in the transition of products from research and development to full-scale manufacturing. Your expertise will ensure that products are designed for manufacturability and that processes are optimized for efficiency and quality.

Key Responsibilities
  • Design Transfer:
    1. Collaborate with R&D, Manufacturing Engineering, and Quality teams to facilitate a seamless transition of products to manufacturing.
    2. Develop and execute comprehensive manufacturing plans that support the transition from initial concept to full production, accommodating new products and modifications.
    3. Design and implement manufacturing processes, including necessary equipment, tooling, and fixtures, to enhance safety, quality, and productivity.
    4. Support process validation efforts, including the development and execution of protocols.
    5. Lead the pFMEA process, DFM/DFA assessments, risk analysis, and establish process control strategies.
  • Process Enhancement:
    1. Work alongside Manufacturing Engineering and Quality to troubleshoot production challenges, identify failure modes, and enhance production efficiency.
    2. Create training materials and provide training for manufacturing staff on newly established processes.
  • Supplier Relations:
    1. Establish and nurture relationships with suppliers to ensure quality manufacturing, materials, and equipment. Identify alternative suppliers when necessary.
  • Cross-Department Collaboration:
    1. Demonstrate persistence and leadership in managing cross-functional teams to integrate new process technologies that align with market demands.
    2. Engage with various departments, including R&D, quality, regulatory, and manufacturing, to address their specific needs.
  • Additional Duties:
    1. Take on further responsibilities as directed by management or senior engineering personnel.
    2. Identify technical risks and resource challenges, proposing effective solutions while fostering trust across the organization.
    3. Contribute to the development of intellectual property.
Qualifications
  • Bachelor's degree in Manufacturing, Mechanical, Electrical Engineering, or a related engineering field.
  • 1-4 years of experience in product or process development.
  • Experience in the medical device, pharmaceutical, or biotechnology sectors is highly desirable.
  • Familiarity with FDA/ISO regulated environments is preferred.
  • Knowledge of quality compliance methodologies such as DFM, DOE, continuous process improvement, and SPC is advantageous.
  • Strong communication and interpersonal skills.
  • Proficiency in design software, particularly SolidWorks.
  • Competence in Microsoft Office 365 applications.
  • Exceptional organizational skills and attention to detail.


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