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Principal Engineer, Design Control NPD

Alcon develops and manufactures innovative devices for eye care needs, including surgical equipment for cataract removal and laser vision correction, and consumer products like Opti-Free contact lens solutions.
Lake Forest, CA, USA
$105,600 - $158,400
Embedded
Principal Software Engineer
In-Person
5+ years of experience
Healthcare · Medical Devices

Job Description

Alcon, a global leader in eye care with over 25,000 associates, is seeking a Principal Engineer for Design Control NPD to join their Research & Development team. This role represents an opportunity to make a significant impact in the medical device industry, specifically in eye care innovation.

The position combines technical leadership with hands-on engineering work in developing complex electro-mechanical equipment and software systems. The ideal candidate will serve as a subject matter expert in design control and risk management processes, ensuring compliance with FDA regulations and international standards while driving innovation in medical device development.

Key responsibilities include developing Design History Files and Risk Management Files, leading design phase reviews, and implementing systematic approaches to requirement management and risk assessment. The role requires deep expertise in medical device development, including electrical, mechanical, optical, and software components, along with thorough knowledge of regulatory requirements and quality standards.

The position offers competitive compensation ranging from $105,600 to $158,400 annually, along with comprehensive benefits including health insurance, life insurance, retirement benefits, and flexible time off. Located in Lake Forest, California, this role provides an opportunity to work with cutting-edge medical technology while contributing to Alcon's mission of enhancing sight and helping people see brilliantly.

The ideal candidate will bring at least 5 years of relevant experience, strong technical expertise in medical device development, and excellent leadership skills. This role offers significant growth potential within a company that's at the forefront of eye care innovation, making it an excellent opportunity for an experienced engineer looking to make a meaningful impact in healthcare technology.

Last updated a month ago

Responsibilities For Principal Engineer, Design Control NPD

  • Support customer business through innovative science and solutions
  • Plan, direct and implement all aspects of design and development of products
  • Develop Design History Files (DHFs) and Risk Management Files (RMFs)
  • Act as Subject Matter Expert on design control and risk management processes
  • Lead Design Phase Reviews and systematic approach to requirement management
  • Lead systematic approach to risk management
  • Coach teams on design control and risk management processes
  • Contribute to research-driven product development
  • Evaluate product performance through in-depth analysis
  • Support regulatory submissions and data validation efforts

Requirements For Principal Engineer, Design Control NPD

  • Bachelor's Degree or Equivalent experience (high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
  • Fluent in English (read, write, understand, and communicate)
  • 5 Years of Relevant Experience
  • Experience in medical device product development (electrical, mechanical, optical, software)
  • Knowledge of Design control for medical devices (21 CFR 820.30, ISO 13485, MDD/MDR)
  • Experience with Risk Management for medical devices (ISO 14971)
  • Knowledge of SW development for medical devices (IEC 62304)
  • Understanding of Medical electrical equipment safety (IEC 60601 series)
  • Experience with Usability Engineering for medical devices (IEC 62366-1)

Benefits For Principal Engineer, Design Control NPD

Medical Insurance
Vision Insurance
Dental Insurance
Relocation Benefits
  • Health insurance
  • Life insurance
  • Retirement benefits
  • Flexible time off
  • Relocation assistance

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