Design Quality Engineer

The Design Quality Engineer will act as the quality representative and design control lead on cross-functional new product development (NPD) and sustaining engineering teams. This role ensures that orthopedic implants and associated instrumentation are developed and manufactured in compliance with internal QMS, FDA 21 CFR 820, ISO 13485, and ISO 14971 standards. The ideal candidate will facilitate risk management activities, verify design outputs, and ensure a smooth design transfer to manufacturing.

• Design Control Leadership: Lead and support Design Control activities (planning, design inputs, outputs, verification, validation, and design transfer) across the product lifecycle.
• Risk Management: Facilitate and lead risk management activities, including development of Risk Management Plans, Hazard Analysis, and Design Failure Mode Effects Analysis (DFMEA) for orthopedic products.
• Verification & Validation (V&V): Approve design verification/validation plans, protocols, and reports to ensure compliance with product requirements, including mechanical testing, tolerance analysis, and anatomical lab testing.
• Design Transfer: Ensure the successful transfer of new products to production by assisting in process validation requirements (IQ/OQ/PQ) and reviewing manufacturing documentation.
• Technical Documentation & Audits: Review and approve Design History Files (DHF) and Device Master Records (DMR) for conformance. Support internal and 3rd party audits (FDA/Notified Body).
• Post-Market Surveillance (PMS): Utilize post-market data and analytics to report on product performance in the field, providing feedback to R&D for continuous improvement.
• Root Cause Analysis: Lead quality-related problem-solving and root cause investigations for design-related issues, complaints, and CAPAs.
• Regulations: Strong understanding of FDA 21 CFR 820, ISO 13485, and ISO 14971.
• Technical
  
  Skills:
  
  Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and machining methodologies (titanium and stainless steel).
• Tools: Proficient in statistical software tools (e.g., Minitab) for data analysis and risk analysis.

• Certified Quality Engineer (CQE), Certified Six Sigma Green/Black Belt.
• Experience with EU MDR regulatory submissions.
• Experience with surgical instrumentation and/or implantable devices.

• Strong analytical, problem-solving, and critical thinking skills.
• Effective communication and interpersonal skills to work within multi-disciplinary, cross-functional teams.
• Detail-oriented with a focus on compliance and accuracy.
• Certified Quality Engineer (CQE), Certified Six Sigma Green/Black Belt.
• Experience with EU MDR regulatory submissions.
• Experience with surgical instrumentation and/or implantable devices.