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 key technical resource.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Support team efforts in establishing program design inputs and/or requirements, ensuring compliance to Arthrex QMS and global standards and regulatory requirements
- Manage completion of Design Control Documentation: Traceability Matrix; Risk Management File; Verification and Validation Plans and Protocols; etc.
- Support team efforts in product complaints review, root cause failure analysis activities
- Support team efforts to develop, track and monitor functional systems needs and reliability throughout a products life cycle, making recommendations on corrective actions and/or potential enhancements.
- Develops and manages product compliance initiatives to relevant standards governing medical electrical equipment.
- Supports the execution of engineering changes, lifecycle changes and/or document changes prior to release.
- Supervises, assigns and/or coordinates 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
- Supports Quality System Audits conducted by external agencies, such as FDA, Notified Body and/or Regulatory Agency audits.
- Contributes to efficient and effective program management
- Ensures 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.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
- Bachelor’s degree in Engineering required; preferably in Biomedical, Electrical, Mechanical, or Chemical Engineering.
- Experience in medical device product development or similar environment preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Experience with full medical device product development cycle preferred.
- 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 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.
Machine, Tools, and/or Equipment Skills:
Experience with electrical medical equipment and accessories development and testing. Understanding of regulatory standards for technical specialty areas as electrical, mechanical, software, chemical and data transfer design standards. Knowledge of surgical equipment and instrumentation, mechanical testing equipment, SolidWorks or other 3D modeling software. MS Office, PC and Databases.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.