Principal Engineer, Product Development

Company: Integra Lifesciences
Location: Irvine
Posted on: May 27, 2023

Job Description:

Overview
Integra LifeSciences -is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.
Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we've evolved into one of the world's leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.
But that's just the beginning. -Integra is growing at an unprecedented rate. We're at a moment in time where the experience you'll gain is more robust than the experience you bring. And we're out to invest in your future because it's the best way to maximize ours.
At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra's ongoing commitment to our values and our shared success.
Integra's health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both.
Regardless of geographic location, our commitment is to offer the following, whenever possible:

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• Benefit plans that meet all local statutory requirements
  
• A range of programs that reflect typical local market practices
  
• An opportunity for employees to tailor benefits to their specific needs
  
• Benefits that balance employee's short-term and long-term needs
  
  Click HERE for more information regarding our benefits and total rewards program
  Responsibilities
  The Principal Engineer, Product Development will lead major system projects of varying scope and complexity across Integra with a focus on the neurological diseases. The Principal Engineer, Product Development will be responsible for the complete development of the mechanical, electrical, software and optical aspects of a project from feasibility to post commercial launch. - They will lead a cross-functional project team through all phases of the product development design control process.
  To be considered for this opportunity you must be able to comply with all customers onsite requirements, including COVID-19 vaccination requirements unless otherwise permitted by law.
  Primary responsibilities are to:
  
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  • Lead the design and development of complex medical device systems from concept to commercial.
    
  • Confirm the usability, safety, and effectiveness of device systems.
    
  • Collaborate with suppliers and customers.
    
  • Lead the cross-functional development team.
    
  • Resolve technical issues by applying theoretical and practical engineering.
    
  • Coach, mentor, and delegate assignments to project staff members.
    
  • Analyze data using statistical and engineering techniques.
    
  • Prepare and review test protocols and reports, drawings, technical specifications, and change orders.
    
  • Ensure compliance with internal SOPs, Design Control and regulatory requirements.
    
  • Stay abreast of emerging technologies, competitors, and intellectual property.
    
  • Identify new and innovative technologies.
    
    Qualifications
    
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    • B.S. or equivalent in a scientific discipline with 9 or more years of applied experience; A M.S. with 7 or more years of applied experience; A PhD with 4 or more years of applied experience.
      
    • Experience developing medical device systems from concept through commercial release.
      
    • Demonstrated experience developing systems requiring multiple technical disciplines, such as mechanical, electrical, optical and software engineering.
      
    • Proficiency with computer aided design (CAD) such as Solidworks or Onshape.
      
    • Expert knowledge of fabrication methods and techniques.
      
    • Highly proficient applying dimensioning and tolerancing drafting standards (GD&T).
      
    • Hands-on mentality.
      
    • Strong understanding of medical device regulations and industry standards.
      
    • Demonstrated ability to manage large system projects.
      
    • Proficiency in statistical data analysis and the ability to utilize appropriate tools, such as Minitab.
      
    • Expertise in Risk Management (Use, Design, and Process FMEA)
      
    • Experience collaborating with functional and technical groups to achieve company objectives, such as Operations, Regulatory, Quality, Software, Packaging, Clinical, etc.
      
    • Excellent technical communication skills, verbal and written.
      
    • Advanced troubleshooting and problem-solving skills.
      
    • Able and willing to mentor junior level staff members.
      

Keywords: Integra Lifesciences, Irvine , Principal Engineer, Product Development, Engineering , Irvine, California