Principal Manufacturing Engineer

Company: EBR Systems Inc
Location: Sunnyvale
Posted on: May 14, 2022

Job Description:

Description:
Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. Heart Failure affects nearly 6 million people in the United States and more than 25 million globally. Some heart failure occurs due to conditions that cause the heart chambers to pump in a desynchronized manner, reducing the amount of blood pumped with each heartbeat. EBR's patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management. We are a team of dedicated individuals, driven to deliver superior treatment of millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective and reliable therapies using wireless cardiac stimulation. As a fast-paced company, every team member at EBR makes a big contribution towards our mission. We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring a ground-breaking technology to market. The Principal Manufacturing Engineer will contribute to all phases of product/process development, transfer to manufacturing, commercial launch, and sustaining support. Support transfer and scale-up of manufacturing to Contract Manufacturing partner(s). Provide technical support as necessary in solving product non-conformances, as well as realizing technical and business opportunities. The Principal Manufacturing Engineer will also help mentor and grow the Manufacturing Engineering organization through knowledge transfer and experience. EBR Systems offers a great place to work as well as generous benefits and growth opportunities:

• Medical, dental, and vision insurance
• 401K
• PTO
• Competitive salary with opportunities for career growth
• Employee stock options
• 401(k) Bonus Program
• Life insurance Duties & Responsibilities:
  • Lead the design and development efforts for significant product and/or process changes and enhancements which reduce defects, improve yields, and lower product costs.
  • Lead, mentor, and execute technical manufacturing projects that improve yield, reliability, manufacturability, capacity, and cost.
  • Create process validation protocols, conduct process optimization studies, conduct process verifications and validations, and generate verification and validation reports.
  • Lead, author and conduct experiments utilizing DOE methodology and other design tools. Accurately generate complex written reports.
  • Design, develop, and implement fixtures and tooling to increase quality, capacity, reliability, and yields.
  • Perform process capability assessments and establish methods to control process output.
  • Write, evaluate, and revise manufacturing risk documents such as MVP and PFMEA's.
  • Work with the R&D, Regulatory/Clinical Affairs, Sales and Marketing, and Quality Assurance functions to coordinate pilot production of new products. .
    
    Requirements:
    Education & Experience:
    • BS in an Engineering discipline such as Industrial and Mechanical or equivalent combination of training and experience.
    • Minimum 10 years of experience with medical device manufacturing experience.
    • Minimum 4 years in a medical device manufacturing environment. Qualifications:
      • Comprehensive knowledge of CAD and drafting tools.
      • Ability to work independently, using good judgment, initiative, and analytical abilities, to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction.
      • Working knowledge of root cause analysis and problem-solving tools for both technical and process issues.
      • Knowledge of Lean and Six Sigma tools.
      • Working knowledge of cGMP requirements for medical device manufacturing per FDA QSR and ISO13485. PI177212338

Keywords: EBR Systems Inc, Sunnyvale , Principal Manufacturing Engineer, Other , Sunnyvale, California