Engineer Sr II - Systems - Medical Devices

 Requisition ID:          60799 Title: Engineer Sr II - Systems - Medical Devices Division: Arthrex, Inc. (US01) Location: INC Santa Barbara CA (ACT) (US17) Salary Range: Salary Minimum: $149,500.00 Salary Maximum:  $224,250.00

 

 

 

 

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The Engineer Sr II – Systems will be responsible for full life cycle development of Class I and II medical devices, which includes initiation, design, development, execution, verification/validation, release, and product maintenance.  Recognized as a technical leader and resource. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

• Develop system architecture documentation
• Establish program design inputs and/or requirements, ensuring compliance to Arthrex QMS and global standards and regulatory requirements
• Decompose product requirements into discipline specific product specifications, collaborating with other engineering functions.
• Manage the completion of Design Control Documentation: Traceability Matrix; Risk Management File; Verification and Validation Plans and Protocols; etc.
• Lead product troubleshooting efforts, including product complaints review and root cause failure analysis activities
• Develop, track and monitor functional systems needs and reliability throughout a products life cycle, making recommendations on corrective actions and/or potential enhancements.
• Perform and develop methods to objectively quantify system performance/function.
• Manage tradeoffs between performance, cost, schedule.
• Integrate all components and subsystems into a functioning system
• Manage product compliance initiatives to relevant standards governing medical electrical equipment.
• Work with notified bodies (e.g., UL, TUV) to demonstrate product compliance to IEC60601
• Support the execution of engineering changes, lifecycle changes and/or document changes prior to release.
• Supervise, assign, and/or coordinate scope and breadth of quality/regulatory testing to be performed to ensure compliance to all ISO and regulatory standards required for a given product or assignment
• Support Quality System Audits conducted by external agencies, such as FDA, Notified Body and/or Regulatory Agency audits.
• Identify and pursue novel technology to support future strategic opportunities.
• Contribute to efficient and effective program management
• Ensure alignment of internal and external customers.
• Some required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.

 

Education and Experience:

Bachelor’s degree in engineering or science required.  Preferably in Physics, Electrical Engineering, Computer Engineering, Computer Science, or Mechanical Engineering.

7 years’ experience in medical device product development or similar environment required. 

 

 

 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

 

• Expert Systems Engineering skills; experience with full product development cycle.
• Demonstrable experienc