Mid-level industry position
Engineer Principal - Electrical
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, particularly related to the design of electronic circuits and associated technologies. Provide technical leadership to the department in the areas of electronic design, research, new or enhanced circuit analysis, simulation methods and technical documentation.
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.
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:
Minimum of a Bachelor of Science Degree in Electrical Engineering; MS or MBA preferred. At least 15 years relevant engineering experiences required. Medical device company experience preferred.
- 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.