Lead Advanced Manufacturing Engineer

2 weeks ago

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

BrioHealth Solutions Inc. is in search of a seasoned and motivated Lead Advanced Manufacturing Engineer to become a vital part of our innovative team. In this role, you will play a crucial part in the project team, overseeing the design and transition of products and process technologies from Research & Development to Manufacturing, ensuring that safety, quality, and regulatory standards are upheld.


Key Responsibilities
  • Design Transition:
    1. Collaborate with R&D, Manufacturing Engineering, and Quality teams to facilitate the transition of products into manufacturing.
    2. Formulate and execute manufacturing strategies to ensure a seamless design transition from initial concept to full-scale production, accommodating new products and enhancements.
    3. Engineer and develop manufacturing processes, tools, and fixtures that align with business objectives while improving safety, quality, and efficiency.
    4. Oversee the creation and execution of all validation plans, protocols, and reports (PC/IQ/OQ/PQ).
    5. Manage the product Cost of Goods Sold (COGS) and guide the project team towards cost-effective solutions during the design phase.
    6. Lead the pFMEA process, Design for Manufacturing (DFM), risk assessments, and process control strategies as part of the project team.
  • Process Enhancement and Support:
    1. Achieve operational goals by collaborating with Manufacturing Engineering and Quality to analyze production challenges and identify solutions to enhance throughput and yield.
    2. Possess a comprehensive understanding of contemporary process technologies, bio/med device assembly methods, and specialized environmental requirements.
    3. Investigate new manufacturing technologies and operational strategies to keep our products at the forefront of innovation.
    4. Develop training materials and provide training for manufacturing staff on newly established processes as necessary.
    5. Assess current and future manufacturing needs, conduct capacity analyses, and implement scaling strategies as required.
  • Supplier Coordination:
    1. Engage with external vendors to resolve capacity or quality concerns regarding components, materials, and subassemblies.
    2. Establish and nurture strong relationships with manufacturing process and equipment suppliers, identifying alternatives as necessary.
    3. Collaborate with Procurement Leaders to explore alternative suppliers when needed.
  • Cross-Department Collaboration:
    1. Demonstrate persistence and determination in organizing, managing, and motivating cross-functional teams to implement and integrate new process technologies to meet market demands.
    2. Work closely with various departments, including R&D, Quality, and Manufacturing, to comprehend their requirements.
  • Additional Duties:
    1. Accept further responsibilities as designated by management.
    2. Guide and mentor junior Advanced Manufacturing Engineers in their professional development.
    3. Identify technical risks and resource challenges, providing solutions.
    4. Engage in the development of intellectual property as required.
Qualifications
  • Bachelor's degree in Manufacturing, Electrical, Mechanical Engineering, or a related engineering field; a Master's degree is advantageous.
  • A minimum of 7 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 (e.g., ISO 9000, ISO 13485, FDA 21 CFR, EU MDR) is preferred.
  • Demonstrated success in managing the transition of complex development projects from R&D to Manufacturing.
  • Experience in creating documentation (plans, protocols, reports, test methods, work instructions, PFMEAs, CAPAs, NCMRs, regulatory submissions) is preferred.
  • Exceptional project management, communication, and interpersonal skills.
  • Proficiency in design software (SolidWorks) and relevant tools.
  • Skilled in Microsoft Office 365 applications and tools.
  • Strong organizational abilities and attention to detail.
  • Leadership qualities with the capacity to mentor and support junior team members.

About BrioHealth Solutions, Inc.

We are a global collective of dedicated Med-Tech professionals committed to patient-centric solutions within a collaborative environment, leading to outstanding outcomes. Our advanced heart failure therapy technology, the BrioVAD Left Ventricular Assist System (LVAS), is being introduced to clinicians treating a significant number of patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATETM Trial in the US marks just the beginning of our journey. We are assembling a team to further develop advanced technology aimed at enhancing patient outcomes, increasing therapy acceptance, and making chronic MCS therapy accessible to more patients worldwide.

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