Staff Engineer, Design Assurance and Reliability Engineering

Company: Integra LifeSciences
Location: Princeton
Posted on: May 28, 2023

Job Description:

Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
SUMMARY DESCRIPTION
SUMMARY DESCRIPTION
The Staff Quality Engineer will work within the Integra Lifesciences CSS Quality organization to support design changes and improvements on our range of Neurosurgical Medical Devices and lead a team of Quality Engineer.
Working in the Design Quality team, you should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. You should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take action, and have excellent written and verbal communication skills. The position will support line extensions of existing products as part of the new product development process, as well as design related aspects of product and process transfers between manufacturing sites. This position will also have responsibility for providing oversight to Quality Engineer/technicians assigned to new product introduction and development to ensure the highest levels of product quality to the end customer.

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  Primary focus is Design Assurnace and Reliability Engineering for new product development, validation, design transfer and new product introduction in the NeuroScience and Speciality Surgical domains. Products include Class I, Class II and Class III medical devices
  
  
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  Provides technical and engineering oversight to staff assigned to product development and key sustaining engineering projects
  
  
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  Provides technical leadership in Continuous Improvement in the areas of Design Control elements including Risk Management, Sterilization Assurance, Stability, Validation, Design Transfer and new product introduction processes
  
  
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  Applies statistical methods and process/design excellence tools to establish test plans, evaluate test data and processes for test methods, process and design verification/validations
  
  
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  Leads development and deployment of Global Operating Procedures for Integra LifeSciences across the Design Control, Validation and Design Transfer domains.
  
  
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  Supports and provides training as part of early adoption, anticipates changes, provides feedback and implements change to support organizational transformation within the Design Assurance and Reliability domain.
  
  
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  Leads transfer to manufacturing activities both in product development and for complex sustaining engineering projects Conducts and lead design verification and validation activities
  
  
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  Provides direct supervision of Quality Engineers and/or Technicians.
  
  
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  Interprets standard and non-standard sampling plans
  
  
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  Supports execution of strategic vision or plan by collaborating with other quality leaders to identify required Quality Engineering skills and competencies
  
  
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  Supports functional and project budget planning and compliance
  
  
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  Represents the Design Assurance and Reliability Engineering function during internal and external audits including FDA
  
  
  The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
  
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    Bachelor's Degree in Engineering (Mechanical, Systems, Chemical or Electrical) or Science (Biology, Chemistry).
    
    
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    3 to 5 years of experience of working within a Medical device or other regulated industry with knowledge of Risk Management (ISO 14971), MDD (Medical Device Directive), ISO 13485 (Quality Management Systems), FDA QSR and cGMP.
    
    
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    Strong analytical skills and a working knowledge of problem solving methodologies
    
    
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    Working knowledge of DFSS techniques
    
    
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    Experience in a Quality Assurance role for medical device or pharmaceutical product development
    
    
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    Knowledge of industry best practices and advances in Risk Management practices, process, tools and technology
    
    
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    Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
    
    
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    Demonstrates excellent organizational, verbal and written communication skills
    
    
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    Proficient with the MS Office Suite, and statistical software (ReliaSoft, MiniTab, FRACAS)
    
    
    Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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Keywords: Integra LifeSciences, Trenton , Staff Engineer, Design Assurance and Reliability Engineering, Engineering , Princeton, New Jersey