Senior Design Quality Engineer

4 weeks ago

Warminster, United States LifeLens Technologies Inc. Full time
Job DescriptionJob DescriptionSalary: Commensurate with experience

LifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative next-generation treatment devices for personal health monitoring. 


We are seeking to hire a Senior Design Quality Engineer. In this role, you will support the design and development of new medical devices through the application of quality engineering practices and principles. You will have a proven track record of supporting design assurance activities including design controls and risk management in the development of new medical products.

 

This is a full-time, on-site position.


Responsibilities:

  • Lead design assurance activities in support of medical device design and development.
  • Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, and verifying implementation and effectiveness of risk controls.
  • Responsible for design controls, quality planning, design reviews, test method development, and design verification.
  • Work with manufacturing engineering to ensure that necessary process controls are in place for design changes.
  • Monitor compliance with quality procedures and FDA QSRs and ISO standards and guide the team as necessary.
  • Act as subject matter expert in design controls and risk management processes.


Qualifications:

  • Bachelor’s Degree in a related discipline (e.g. Engineering, Physical or Life Science) with an advanced degree preferred.
  • Minimum 5 years experience in medical device design quality assurance.
  • Direct experience in design controls and risk management activities.
  • Knowledge of FDA regulations and international standards for medical devices is preferred.
  • Demonstrates strong knowledge of quality engineering principles and best practices.
  • Certified Quality Engineer (CQE) certification is a plus.


Benefits:

  • Health Insurance
  • Dental & Vision Insurance
  • Stock Options
  • Paid Time Off
  • Flextime

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