Our Arthrex locatiohn in beautiful Santa Barbara, CA is seekikng a Principal Electrical Engineer with a strategic and continuous improvement mindset. Individual will be responsible for full life cycle development in the development of Class II and II medical devices including surgical camera systems and electo-mechanical arthroscopic systems for operating rooms worldwide.
Qualified candidates have proven success in confidently providing technical leadership to a department in the areas of research and development of new and/or enhanced electronic design, circuit analysis, and simulation methods in a matrix environment. Must have a bachelor’s degree or higher in Electrical Engineering and a minimum of fifteen years of relevant experience.
Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™!
Essential Duties and Responsibilities:
Lead teams in the management and completion of Design Control Documentation: Traceability Matrix; Risk Management File; Verification and Validation Plans and Protocols. Ensure compliance to Arthrex QMS and global standards and regulatory requirements.
Work with multidisciplinary teams of design, software, mechanical, test, and production engineers to create new medical electronics hardware.
Support the execution of engineering changes, lifecycle changes and/or document changes prior to release.
Support Marketing and Product Management with technical information to be used for training and marketing of assigned products as needed.
Ensure alignment of internal and external customers.
Create and optimize test plans including Design V&V protocols and may perform and/or manage these tests including results and conclusions.
Select and specify electronic and electrical components based on function, cost, availability, reliability, etc. for the use in the products manufactured
May be required to provide sustaining support for existing product lines. This may include component second sourcing, analysis and resolution of field issues and/or manufacturing issues.
May be required to support development of budgets and timelines for projects and design history file deliverables for assigned projects, adhering to design control procedures.
Contribute to efficient and effective program management. Report progress and status of assigned projects on a timely basis.
Lead 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.
Provide Regulatory department technical support for assigned projects as needed.
Some required international/domestic travel to support vendors and/or customers may be required.
Education and Experience:
Bachelor of Science Degree in Electrical Engineering required; MS or MBA preferred.
15 years relevant engineering experiences required.
Medical device company experience preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Expert understanding of electronic design, EMC/EMI mitigation, manufacturing and assembly.
Experience with full product development cycle from concept and testing to production release.
Working knowledge of medical device regulations and associated quality systems, particularly design controls and risk management.
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.
Must have hands-on experience excited to work in a fast-paced environment.
Ability to confidently lead and/or support complex, cross functional teams independently.
Knowledgeable of FDA and ISO guidelines for the development of medical devices preferred.
Strong communication skills and accountability to project deliverable timing.
Continuously seeking ways to improve complex systems of people, processes and/or technologies.
Working knowledge of medical device electrical safety standards preferred.
Knowledge of orthopedic surgery preferred.
Machine, Tools, and/or Equipment Skills:
Experience with electrical medical equipment and accessories development and testing.
Understanding of domestic and international electrical safety regulatory standards.
Knowledge of oscilloscopes, spectrum analyzers, network analyzers, logic analyzers, waveform analyzer, electrical testing equipment, PC and instrumentation.
Bench top testing and troubleshooting with typical lab equipment. 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.
