Design Assurance Engineer

Orthofix • Lewisville, TX

121d

About The Position

This position is responsible for providing Design Assurance support to product development activities, selected sustaining, and specials projects within Orthofix. The position must also ensure compliance with applicable product standards, governing laws and regulations, and company quality system requirements.

Requirements

• Bachelor's degree in mechanical or electrical engineering
• 3-5 years of relevant experience
• Root cause analysis, problem solving, continuous improvement
• Excellent technical writing skill and ability to communicate well (both written and verbal) laterally and vertically
• Excellent time management and ability to balance multiple deliverables simultaneously
• Logical cognitive skills and ability to apply scientific methods
• Ability to identify variables affecting quality
• Ability to meet deadlines and/or objectives as directed

Nice To Haves

• ASQ Certified Quality Engineer (CQE)
• Master's degree in engineering
• Software design, IEC 62304, cybersecurity
• Worked with Spinal or Orthopedic medical devices
• Medical device or other health-related field experience
• CAD

Responsibilities

• Participate as a product development cross-functional core team member
• Ensure project design controls requirements are being met
• Educate and guide product development team on quality and design controls best practices
• Collaborate with multiple disciplines to ensure completion of project objectives
• Risk management and hazard analysis
• Reliability and failure analysis, FMEAs
• Design validation plan and protocol development
• Evaluate design changes for impact to standards and product essential performance
• Establish acceptance criteria and ensuring compliance with technical standards
• Biocompatibility and Sterilization
• Review specifications to ensure appropriate dimensioning and tolerances
• Input to process development and design for manufacturing
• Input to and approval of process validation activities
• Measurement System Analysis
• Input to, and development of, specifications, standards, test protocols, test reports, procedures and other documentation and records related to design and development
• CAPA/NCMR investigations

What This Job Offers

• Job Type: Full-time
• Industry: Wholesale Trade Agents and Brokers
• Education Level: Bachelor's degree