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Senior Design Assurance Engineer

2 months ago

Orange, California, United States Veranex Full time
About This Role:

Veranex is a global leader in medical technology innovation, and we're seeking a highly skilled Senior Design Assurance Engineer to join our team. As a key member of our New Product Development team, you will play a critical role in ensuring the quality and safety of our medical devices.

Key Responsibilities:
  • Develop and implement risk management plans and reports, hazard analyses, and Failure Mode & Effects Analysis (FMEA) for novel and existing medical devices.
  • Collaborate with cross-functional teams to design and develop highly complex medical devices, ensuring compliance with relevant quality system regulations.
  • Provide quality insight and leadership on program teams, and assist with establishing appropriate build quality controls.
  • Ensure the successful integration of quality assurance and regulatory compliance during design and development.
  • Develop, document, and validate inspection and test methods to support development.
  • Support internal and external audit activities, and participate in design reviews.
  • Train and mentor new and less experienced engineers.
Requirements:
  • Bachelor's or Master's degree in quality, engineering, or a related field.
  • 4-6 years of relevant work experience in medical devices, or an equivalent combination of education, experience, and training.
  • Expertise in ISO13485 and ISO14971, with experience in ISO10993, IEC60601, IEC62304, IEC62366, MDR, and IVDR.
  • Strong understanding of FDA Quality System regulations, European Active Implantable & Medical Device Regulations, and relevant medical device principles.
  • Excellent written and oral communication skills, with excellent attention to detail.
What We Offer:

Veranex is an equal opportunity employer, and we offer a competitive salary range of $89,200.00 to $127,490.00. We are committed to creating a diverse and inclusive work environment, and we welcome applications from qualified candidates.