Electrical Engineer Fellow

About the role

The AIS Electrical Hardware R&D team is looking for an experienced Electrical Engineer Fellow to provide expertise in definition, design, development and test for our active implantable medical device portfolio. As a key member of the electrical hardware design team, you will drive the creation, implementation, and continuous improvement of our electrical design of active implantable devices ensuring the reliability, safety, and performance of life-changing medical devices.

Responsibilities

• Designs, develops, debugs, modifies, and tests electrical circuits and systems by using current tools, analysis techniques, and technologies.
• Documents electrical development by writing documents, reports, memos, change requests.
• Establish strategies for MRI testing and evaluation of implantable devices.
• Tracks electrical development effort by creating and maintaining records in the approved tracking management tool to include utilizing multiple version control, defect tracking, and peer review tools including Accurev, JIRA and Windchill.
• Solves engineering problems by analyzing the situation and recommending corrective or alternative actions.
• Analyzes, evaluates, verifies, requirements, circuits, and systems by using engineering practices.
• Solves a range of problems of varying scope and complexity, generally applying existing solutions, while exercising autonomy to propose alternatives to understanding their impact on the business or applying judgment based on experience to develop new solutions.
• Create schematics, layouts, BOM’s and other design outputs as needed utilizing Altium Designer.
• Communicates clearly with cross-functional and cross-divisional stakeholders, providing concise technical updates and enabling informed decision-making.
• Collaborate effectively with process development, quality, manufacturing, and regulatory teams to ensure comprehensive, compliant test solutions.
• Provides technical leadership, mentoring, and direction to engineers and technicians in automation development and execution.

Requirements

• BS in Electrical Engineering or related field.
• 10+ years of Electrical Engineering experience within the medical device industry or highly regulated industry.
• Ability to collect, organize, synthesize, and analyze data; summarize findings; develop conclusions and recommendations from all stakeholders using all sources of data.
• Ability to analyze test results and perform risk analysis.
• Ability to interpret and research requirements, specifications, and input/output processes.
• Experience with change management and issue tracking tools such as JIRA, AccuRev, Windchill etc.
• In-depth conceptual, practical and technical and/or functional knowledge of principles and theories of board level electrical engineering and general understanding of related job functions.
• Strong lab experience including troubleshooting, iterative testing, fixture development/usage, and the operation of test equipment (oscilloscopes, power supplies, multimeters, etc.).

Qualifications

• 10+ years of experience in hardware engineering.
• 7+ years’ experience automated and manual testing in regulated industry, preferably in active implantable medical device domain.
• 7+ years’ experience in system development lifecycle process including formalized processes and procedures.
• Create protocols, automate tests, general experience in Perl, Python, HTML, scripting or equivalent.
• Experience with medical device electronics and systems.
• Experience using electrical engineering analysis techniques to map high-level requirements into circuit specifications.
• Ability to solve complex problems with root cause analysis, including designing and executing experimental plans and using statistical methodologies to drive data-based decisions.
• Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources.
• Excellent organizational, communication, and collaboration skills.
• Ability to work independently to plan, schedule, and execute activities to meet project timelines and objectives.
• Experience with standards like ISO 10974, PC76 or equivalents.
• Participation in the development of standards.