Senior Design Quality Assurance Engineer

21 hours ago


Andover, Massachusetts, United States Smith & Nephew Full time
Job Summary

We are seeking a highly skilled Sr. 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 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.
  • Assist in preparation for regulatory submissions and provide support during audits and inspections.
  • Lead or assist in process improvement and CAPA, utilizing tools such as six sigma or lean manufacturing.
  • Research and provide insight into current trends in design control and risk management, following new standards and regulations.
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 with strong working knowledge of FDA QSR and ISO 13485.
  • Risk Management per ISO 14971 and Medical device software development per IEC 62304 preferred.
  • Background in machine learning, digital image processing, AI, or computer vision preferred.
What We Offer
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and collaborative work environment.
  • Recognition and rewards for outstanding performance.
Why Join Us

At Smith+Nephew, we are committed to creating the greatest good for society. We believe in the importance of diversity, equity, and inclusion, and we strive to create a workplace that is welcoming and inclusive for all employees. We offer a range of benefits and programs to support the well-being and success of our employees, including flexible work arrangements, professional development opportunities, and a comprehensive benefits package.



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