Design Quality Engineer

5 days ago


Andover, Massachusetts, United States Smith & Nephew Full time
About the Role

We are seeking a highly skilled Design Quality Engineer to join our team at Smith+Nephew. As a key member of our Quality Department, you will play a critical role in supporting new product development (NPD) activities for Arthroscopic Enabling Technologies products.

Key Responsibilities
  • Support the completion of Design Control and Risk Management requirements to ensure the delivery of safe and effective products to the market.
  • Provide guidance and instruction to more junior engineers while working collaboratively to support active NPD programs.
  • Subject matter expert for technical design reviews, including SW code reviews, and responsible for compiling and presenting quality data to key stakeholders and leadership.
  • Assist in preparation for regulatory submissions and provide support during audits and inspections.
  • Work cross-functionally to influence key stakeholders and train quality engineers on design control, software quality, and print interpretation/reviews.
Requirements
  • Minimum BS in engineering or a technically related field; MS preferred.
  • 3-5 years of relevant experience in Medical Device Design Controls and/or Quality Systems.
  • Considerable hands-on experience in FDA QSR and ISO 13485, Risk Management per ISO 14971, and Medical device software development per IEC 62304.
  • Background in machine learning, digital image processing, AI, or computer vision preferred.
What We Offer
  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A comprehensive benefits package, including medical, dental, vision, and 401k matching.
  • A hybrid work model with flexibility to work from home.


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