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Quality Design Engineer II

1 month ago

Largo, Florida, United States CONMED Corporation Full time

The Design Quality Engineer is a key member of the cross-functional development and sustaining teams at CONMED Corporation. This role is responsible for ensuring compliance to ISO, EU MDR, and FDA QSR requirements for Medical Devices. The Design Quality Engineer will serve as the quality engineering contact and lead quality initiatives with inter-organizational impact.

Key Responsibilities:

  • Supports product development teams for quality deliverables.
  • Ensures product design meets customer expectations, regulatory requirements, and corporate standards.
  • Reviews and approves product design documentation for compliance.
  • Troubleshoots and directs the resolution of quality issues through effective partnerships.
  • Focuses on the safety and efficacy of medical devices.
  • Reviews and approves design verification and validation protocols.
  • Leads risk management activities for clinician and patient safety.
  • Supports product development through capability assessment and quality tool development.
  • Investigates process and product issues through complaints and trend analysis.

Requirements:

  • Bachelor's degree in Engineering (Electrical, Mechanical, Chemical, or Biomedical) with 2+ years of medical device experience.
  • Advanced degree considered in lieu of experience.

Preferred Qualifications:

  • Knowledge of design controls, 21 CFR 820, ISO 13485, and applicable medical device regulations.
  • Professional certifications (CQE, CQA, CMQ/OE, Lead Auditor) desirable.
  • Design for Six Sigma training and statistical methodologies knowledge desired.