Senior Advanced Manufacturing Engineer 

Job Description

BrioHealth 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. 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 Engineers and Quality to transfer products to manufacturing.
  2. You will lead the design transfer process and ensure all activities are being completed per the project plan and that all processes are production-ready.
  3. You will design and develop manufacturing processes, tooling, and fixtures to meet business needs while enhancing process safety, quality, and productivity.
  4. You will be responsible for all process validation activities (e.g., development and execution of IQ/OQ/PQ).
  5. Create validation plans, protocols and reports.
  6. You will be responsible for product Cost of Goods Sold (COGS) and drive the project team toward cost effective solutions during concept and design selection.
  7. As part of the project team, you will be responsible for leading the pFMEA process.

• Process Support and Improvement:
  1. Work with Manufacturing Engineering and Quality to investigate production issues to improve production throughput and yields.
  2. You must possess a modern understanding of new technologies, commercial fabrication techniques, etc.
  3. Develop processes for prototype and pilot production of new products, product changes, and enhancements in coordination with R&D and Quality functions.
  4. Train manufacturing personnel to newly developed processes.

• Supplier Management:
  1. Build and maintain strong relationships with suppliers for manufacturing processes and equipment. Identify alternative suppliers as needed.
  2. Work with Procurement Leaders at BrioHealth Solutions to identify alternative suppliers as needed.

• Cross-functional Collaboration:
• Work closely with various departments, including R&D, quality and manufacturing, to understand their needs.

• Other:
  1. Accept other responsibilities as assigned by supervisor or Staff Engineer.
  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 expected

Requirements

•  Bachelors degree in Mechanical Engineering or other engineering discipline. Masters 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

• Proven track record of successfully managing the transfer of complex development projects from R&D to Manufacturing.

• 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.

• 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.