Senior Design Assurance Engineer - Spinal Implants

Company: Orthofix
Location: Lewisville
Posted on: March 13, 2023

Job Description:

Why Orthofix?

Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun! As an Orthofix employee, you will become an integral part of our culture by continually demonstrating the highest level of integrity and our beliefs while making an impact to our vision "To be a highly respected global orthopedic and spine company that delivers exceptional value to our patients, customers, team members, partners and shareholders."

Senior Design Assurance Engineer - Spinal Implants
How you'll make a difference?

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

What will be your Duties and Responsibilities?

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. For assigned area and products:

DA Engineer must participate as a product development team member and must have technical competencies to educate, direct, manage on the teams and complete the following.

• Risk management,
• Reliability and failure analysis,
• Root cause analysis, problem solving, continuous improvement and related corrective and preventive action as they relate to complaints, non-conforming material, post-market surveillance (PMS), and other quality data
• Quality Planning,
• Input and approval for design verification and validation testing of new designs and design changes to ensure product design quality and integrity
• Generate protocols and implement validation testing products
• Establishing acceptance criteria
• Evaluating design changes
• CAPA/Non-Conformance investigations
• Process Development/Management,
• Defining and ensuring compliance with technical standards,
• Standards updates and compliance
• Determine appropriate tests and validations to ensure components and products meet specification requirements
• Input to, and development of, specifications, standards, test protocols, test reports, procedures and other documentation and records related design and development
• Review specifications to ensure appropriate quality system, compliance, design, dimensioning and tolerancing What skills you'll need?
  • Bachelor's degree in Mechanical, Electrical, or Software engineering or related field
  • Excellent technical writing skill and ability to communicate well (both written and verbal) laterally and vertically.
  • Project planning and management a must.
  • Able to balance multiple projects as same time.
  • Computer knowledge: MS Word; MS Excel, MS Project, etc
  • Logical cognitive skills and ability to apply scientific methods
  • Ability to identify variables affecting quality
  • Ability to meet deadlines and/or objectives as directed Nonessential Skills, Experience and Qualifications (not necessary but preferred):
    • Master's degree in Mechanical engineering or similar field
    • Experience with Spinal products
    • Medical device or other health-related field experience
    • Capable of interpreting GD&T
    • CAD
    • ASQ Certified Quality Engineer (CQE)
    • Technical Writing Supervisory Responsibilities:
      • N/A PHYSICAL DEMANDS AND WORK CONDITIONS:
        
        The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
        • Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 40 lbs.
        • Must be able to work in a laboratory environment.
        • Eyesight and hearing must be correctable to standard level.
          
          Orthofix complies with all applicable federal, state, and local laws regarding equal employment opportunities (EEO) to all employees and applicants for employment. Orthofix makes its employment decisions without regard to race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by law. In addition to federal law requirements, Orthofix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Keywords: Orthofix, Lewisville , Senior Design Assurance Engineer - Spinal Implants, Engineering , Lewisville, Texas