Job Overview
The role requires close collaboration with project leadership and cross-functional teams to ensure safe, compliant, and effective integration of implantable medical device technologies.
Key responsibilities include:
- Identifying gaps in acquired company compliance to work instructions and SOPs and defining strategies to close those gaps
- Providing input to project goals, tracking progress, and recommending revisions as needed
- Communicating progress, risks, and trade-offs of technical deliverables to project leadership
- Completing complex or novel engineering assignments, including development of new or improved techniques and procedures
- Executing electrical design remediation, product design refinement, specification development, test method validation, and report preparation
- Assessing feasibility and soundness of alternative engineering approaches, products, or equipment
- Contributing to design hazard analysis, FMEA, and compliance with design control and risk management SOPs
- Producing clear, concise engineering documentation to support knowledge transfer during product integration
- Collaborating with external partners and suppliers on component specifications, qualification and acceptance activities, testing protocols, and quality standards
Must-Have Qualifications
- Bachelor's degree in Electrical Engineering
- 4+ years of professional electrical engineering experience
- Medical device industry experience
- Experience with implantable medical devices, including testing
- Strong experience with electrical and/or systems engineering design documentation
- Ability to prepare and validate test methods and write technical reports
- Ability to analyze technical inputs from multiple sources and make sound engineering recommendations
- ***Must be able to travel up to 10% during length of assignment. Mostly local travel.
Preferred Qualifications
- Familiarity with IEC 14708 and ISO 45502 active implantable medical device standards
- Familiarity with IEC 60601 electrical medical equipment standards
- Experience with test fixture design and implementation
- Analog and digital circuit design experience
- Experience using LTspice or equivalent electrical simulation tools
- Experience using Altium for schematic capture and PCB design
- RF design and test experience
- Hands-on electronics troubleshooting experience
- Experience with medical device design acceptance and design verification testing
