Quality Engineer II

Company: Element Science, Inc.
Location: Redwood City
Posted on: September 17, 2023

Job Description:

THE COMPANY: -
Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home. By putting the needs of patients and physicians first, our personalized digital devices, which are designed for function, comfort, and ease-of-use, aim to redefine the paradigm of care for these patients. - Our first product, a wearable patch defibrillator, is initially targeted at treating the more than 500,000 patients in the US with an elevated temporary risk of potentially experiencing a lethal heart rhythm. - Based in San Francisco, our funders include Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.
RESPONSIBILITIES:

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• Provide Quality Engineering support to product development team in the area of Design Control to ensure compliance to the QSR Design control requirements.
  
• Participates in developing or improving Standard Operating Procedures and/or Work Instruction as part of the Quality System procedure.
  
• Perform internal audit to various design and development areas to ensure compliance to the QS SOP and WI.
  
• Responsible in managing Design Verification testing including writing test protocols, execution of verification testing and non-human design validation testing.
  
• Participates in cross-functional meetings with internal and external parties as required.
  
• Participate in new supplier evaluation, work with suppliers to ensure appropriate quality deliverables and activities are implemented as needed.
  
• Facilitate NCR, CAPA and Complaints process execution.
  
• Supports management and tracking of quality system records (e.g. DHF audit, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental targets.
  
• Lead the development of DFMEA and Risk Analysis per ISO 14971 along with development team, support other activities such as Test Method Validation on Design Verification Testing.
  
• Supports management review process through development and generation of quality system metrics and generate quarterly data for those metrics. Help the management in creating QMR presentation slides for some QS elements as assigned.
  
• Implement appropriate Quality engineering practices including statistical analysis, root cause analysis, and reliability engineering.
  
• Other tasks as assigned by the management.
  
  QUALIFICATIONS:
  
  • 
    
  • 4+ years of relevant experience in Medical Device environment Quality System.
    
  • Demonstrates working knowledge of current ISO 13485 standard and QSR.
    
  • Bachelor's Degree in Science or Engineering, Master's degree is a plus.
    
  • Ability to work in a team environment, manage multi-tasking, and discipline in completing tasks on schedule.
    
  • Excellent written and verbal communication skills.
    
    BENEFITS:
    Element Science offers a very competitive salary and benefits package including, but not limited to:
    
    • 
      
    • Stock Options
      
    • 90% employer-paid medical, dental, and vision insurance
      
    • Company-paid Basic Life Insurance
      
    • 401(k) retirement plan (Traditional and Roth)
      
    • Competitive Paid Time Off
      
    • Paid Holidays
      
    • FSA (Flexible Spending Accounts)
      
    • HSA (Health Savings Account)
      
    • Employee Assistance Program through PEO
      
    • The salary for this exempt-level position will be based on experience and qualifications within an established pay range.
      
    • Pay range: $100,000 - $120,000 (negotiable based on experience)
      
      

Keywords: Element Science, Inc., Redwood City , Quality Engineer II, Engineering , Redwood City, California