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.
8 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 experience with medical device product development from concept and testing to production release.
Strong strategic thinker, excellent collaboration and communication skills, careful attention to detail
Ability to balance business and technical risks while remaining compliant with internal systems.
Working knowledge of medical device regulations and associated quality systems, particularly design controls and risk management.
Understanding of Design for Manufacturability, including manufacturing process optimization support, and Design for Cost.
Understanding of Design for Quality with tools such as FTA, FMEA, etc.
Manufacturing process knowledge preferred.
Awareness of orthopedic surgery principles, theories, and products preferred
Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
Technical knowledge in development methodologies, design and test in support of program release.
Ability to confidently lead and/or support complex, cross functional teams independently.
Continuously seeking ways to improve complex systems of people, processes and/or technologies.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.
