Senior Design Assurance Engineer

Why Orthofix?
    

Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech.  

Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further.

How you'll make a difference?

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. 

What will your duties and responsibilities be?

The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.

• 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 skills and experience will you need?

The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.

Education/Certifications:

• Bachelor’s degree in mechanical or electrical engineering

Experience, Skills, Knowledge and/or Abilities:

• 5-10 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.

What qualifications are preferred?

The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

Education/Certifications:

• ASQ Certified Quality Engineer (CQE)

• Master’s degree in engineering

Additional Experience, Skills, Knowledge and/or Abilities:

• Software design, IEC 62304, cybersecurity

• Worked with Spinal or Orthopedic medical devices.

• Medical device or other health-related field experience

• CAD

PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS

The physical requirements listed in this section include but are not limited to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position.