Senior Electrical Engineer

Imricor Medical Systems Inc•Burnsville, MN

12d•$100,000 - $140,000•Onsite

About The Position

Imricor is seeking a Senior Electrical Engineer to lead the design, development, and validation of electrical systems for its MR-conditional cardiac intervention platform. The successful candidate will play a critical technical leadership role across the full product lifecycle for capital equipment and supporting subsystems - from concept and architecture through verification, validation, and deployment. This position is responsible for complying with MR safety, medical device regulations, and Imricor’s Quality Management System, and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Requirements

Bachelor’s degree in electrical engineering or related field (Master’s degree preferred).
7+ years of experience in electrical engineering, with extensive experience in designing electrical systems for medical devices or capital equipment.
Strong knowledge of analog and digital circuit design, power distribution, grounding, and shielding.
Proficient computer skills including experience with schematic capture and board layout (preferably Altium), circuit simulation, and Matlab/Octave.
Working knowledge of FDA design controls and IEC 60601 standards as well as overseeing testing completed by certified test labs.
Ability to communicate concepts, ideas, and knowledge effectively and clearly to other individuals and teams.
Strong analytical and problem-solving skills.
Experience with Good Documentation Practices (GDP).

Nice To Haves

Direct experience designing MR-conditional capital equipment.
Familiarity with MR physics, RF systems, and electromagnetic compatibility in MR environments.
Experience supporting regulatory submissions (FDA 510k, PMA, and CE marking).
Exposure to electrophysiology, interventional cardiology, or image-guided therapy systems.

Responsibilities

Consults and solicits feedback from internal stakeholders to identify customer needs and translate these requirements into designs.
Leads electrical system architecture development and the design and evaluation of electrical components, enclosures, and systems to ensure availability, performance, and cost requirements are met.
Develops optimized product solutions from concept to manufacturing through risk analysis (DFMEA), prototyping, and design iterations using engineering principles, human factors/usability, and design for manufacturability practices.
Defines and executes electrical verification and validation plans, including bench testing, system integration, and agency testing. Ensures electrical designs meet IEC 60601 standards and applicable FDA and CE requirements.
Leads root cause analysis and resolution of electrical issues discovered during development, verification, or clinical use.
Supports reliability testing, tolerance analyses, and design-for-manufacturability activities.
Responsible for successful product launch through product development process by working cooperatively with R&D, Design Assurance, Quality, Manufacturing, Regulatory, Clinical, and Marketing. Create and execute change orders to document and implement changes.
Provides electrical engineering leadership during design reviews, risk analyses, and change control activities.
Supports manufacturing transfer, supplier technical engagement, and post-market engineering support.
Supports product life cycle by addressing supply chain and quality issues in collaboration with Operation and Quality.
Generates and maintains design documentation including input requirements, design output, risk analysis, test methods, verification and validation plans/reports, and manufacturing processes.
Contributes to design history files, risk management files, and regulatory technical documentation.
Performs other related duties and responsibilities as assigned in compliance with Imricor’s Quality Management System.