Senior Advanced Manufacturing Engineer

Job DescriptionBrioHealth Solutions Inc., Inc. is seeking an experienced and driven Senior Advanced Manufacturing Engineer to join our dynamic team. As a Senior Advanced Manufacturing Engineer, you will be an integral member of the project team and lead the design and transfer of products and process technologies from R&D to Manufacturing ensuring safety, quality, and regulatory goals are met. Specifically, you will be responsible for Design for Excellence and process development. Your expertise will contribute to the organization's operational efficiency and overall success.Responsibilities

• Design Transfer:
  1. As a member of the project team, you will work closely with R&D, Manufacturing Engineering and Quality to transfer products into 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 design and develop manufacturing processes, associated equipment, tooling, and fixtures to meet business needs while enhancing process safety, quality, and productivity.
  4. You will be responsible for creating and executing all validation plans, protocols, and reports (PC/IQ/OQ/PQ).
  5. You will be responsible for the product Cost of Goods Sold (COGS) and drive the project team toward cost effective solutions during concept and design selection.
  6. As part of the project team, you will be responsible for leading the pFMEA process, DFM/DFA, risk analysis and process control strategies.

• Process Support and Improvement:
  1. Achieve Operations deliverables by working with Manufacturing Engineering and Quality to investigate production issues, identify failure modes to improve production throughput and yields.
  2. You must possess a broad understanding of current process technologies, bio/med device assembly methodologies, commercial fabrication techniques, creating and maintaining specialized environments, etc.
  3. You will research new manufacturing technologies and operational methodologies to ensure our products remain innovative and cutting edge.
  4. Provide training materials and training for manufacturing personnel for newly developed processes as needed.
  5. You will quantify current and future manufacturing requirements, perform capacity analyses, and implement capacity scale-up as required.

• Supplier Management:
  1. Interface with outside vendors to address capacity or quality issues with components, materials, and subassemblies.
  2. Build and maintain strong relationships with manufacturing process and equipment suppliers. Identify alternative suppliers as needed.
  3. Work with Procurement Leaders at BrioHealth Solutions to identify alternative suppliers as needed.

• Cross-functional Collaboration:

1. 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.
2. Work closely with various departments, including R&D, quality and manufacturing, to understand their needs.

• Other:
  1. Accept additional responsibilities as assigned by manager or Operations management.
  2. Mentor and develop junior level Advanced Manufacturing Engineers toward professional growth.
  3. Identify technical risks, resource problems and work arounds.
  4. Development of intellectual property is required.

Requirements

• Bachelor’s degree in Manufacturing, Electrical, Mechanical Engineering or other engineering discipline. Master’s degree is a plus.
• Minimum of 7 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.
• Proven track record of successfully managing the transfer of complex development projects from R&D to Manufacturing.
• Experience creating documentation (plans, protocols, reports, test methods, work instructions, PFMEAs, CAPAs, NCMRs, regulatory submissions) is preferred.
• Excellent project management, 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.
• Leadership skills and the ability to mentor and guide junior team members.

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.