Design Quality Engineer

About Enovis

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit

At Enovis we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit of scientific excellence - with the goal of transforming medical technology as we know it.

Because that’s how we change the lives of patients for the better. And that’s how we create better together. Why work at Enovis? See for yourself.

As a key member of the Quality Design Team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

• Job Title:
  
  Design Quality Engineer
• Reports To:
  
  Director, QA | QC
• Location:
  
  Carlsbad, CA (Hybrid 3 days onsite 2 days remote)
• Business Unit
  
  Description:
  
  Bracing & Supports
• Job Title/High-Level
  
  Position Summary:
  
  The Design Quality Engineer position is responsible to implement and lead Design Quality Engineering activities at the Enovis design and production location(s) as assigned. The Design Quality Engineer will support priority Product Development and Sustaining Design Engineering projects as the lead Quality Engineering technical representative. This position will be responsible to assure product designs meet our compliance with FDA regulations, ISO 13485 and global regulatory standards and Company strategies.
  
  The position will report directly to the Manager of Design Quality.

• Assists process owners to write and issue procedures to assure compliance with the current FDA QSR regulations, ISO 13485, CMDR and Medical Device Directive requirements; and to provide training to process owners related to Quality Management System requirements, as necessary. By the way of example and not exclusion, process may include Standard Operating Procedures (SOP's) manufacturing and design processes, inspection procedure and test procedures.
  
  Review and approve completed procedures to assure compliance with content and regulatory requirements.
• Support Design Quality Engineering Assignments, including New Product Introduction (NPI) projects, Corporate priority projects and sustaining support. Quality Engineering Responsibilities may include:
  • Support, Review and Approve Design Specification packages
  • Support, Review and Approve Material and Product Test Plans
  • Review and Approve Design Engineering Drawings
  • Review and Approve Design Verification and Validation Test Protocols and Reports
  • Support Design Transfer activities:
    Develop inspection and testing methods, plans to perform First Article Approvals and lead execution of First Article inspections.
• Support Sustaining Design Quality Engineering Assignments, including ensuring verification and validation for design changes for product and process improvements, component end of life transition, and quality improvements.
• Lead Risk Management process for assigned products and projects, coordinating development and implementation of risk management plans, hazard analyses, design and process failure modes and effects analyses (as applicable).
• Support Design History File establishment, creation, approval and maintenance
  • Perform Design History File audits at Phase Gates to ensure product development projects are in compliance to applicable design control regulations and company policies and procedures.
• Coordinate Supplier Approvals for NPI projects with Supplier Quality Assurance in accordance with Enovis Supplier Approval process.
• Support, Review and Approve Design Transfer activities to ensure design quality performance requirements are properly transferred, which may include IQ, OQ, PQ, Process Validation, and updated Inspection Plans.
• Attend and support Project team meetings, collaboration…