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Gilero, A Sanner Group Company · 4 days ago

Senior Electrical Engineer - Medical Device

Triangle Area

Full-time

Onsite

Senior Level

5+ years exp

Gilero is a leading medical device design, development, and manufacturing partner, specializing in innovative solutions that enhance patient care. They are seeking a highly skilled Senior Electrical Engineer to lead the development of complex medical devices, ensuring compliance with regulatory and quality standards while contributing to innovative healthcare solutions.

ManufacturingMedical DevicePharmaceuticalProduct Design

Growth Opportunities

No H1B

U.S. Citizen Only

Hiring Manager

Tricia (Grabfelder) Lucas, MBA

Responsibilities

Acts as technical lead throughout the full product development lifecycle from initial concept to release to market of new medical devices; primarily class I and class II electro-mechanical devices

Designs mixed signal, analog, power, and digital circuit design; including schematic capture and layout of PCBAs

Prepares detailed block diagrams, circuit schematics, and component specifications

Documents the design of hardware and facilitate the formal release process for medical devices, satisfying applicable quality and regulatory requirements

Performs high-level circuit simulations

Leads and performs hardware testing and debugging for medical device safety and EMC standards

Investigates, evaluates, and selects electronic components

Supports custom firmware development and testing

Works with component and assembly vendors to ensure designs can be efficiently and cost-effectively manufactured

Leads and participates in writing product and customer requirements, design and phase reviews, product and process risk assessments, root cause investigations, and corrective action planning

Plans, authors, and executes test methods and protocols for design verification and validation

Analyzes test data, interprets results, and formulates conclusions

Maintains the Design History File (DHF) and ensures documents are complete, accurate, current, and compliant with regulations

Contributes to developing electrical engineering tools and processes and trains others to use those systems

Identifies technical opportunities and generates work for themselves within their assigned project teams

Defines objectives, participates in, and oversees quality of output for large or complex projects

Contributes to solving open-ended problems and tasks with a high level of decision making

Formulates and develops detailed project deliverables with some management oversight

Communicates technical risks and proposed solutions clearly and directly with the customer

Sources and interfaces with third party vendors

Acts as subject matter expert (SME) lead in one or more areas and is aware of industry trends

Supports business development efforts as a SME to potential customers and providing input on engineering estimations

Establishes a proven track record of building trust and rapport with new clients

Acts as mentor demonstrating strong leadership skills

Participates in recruitment activities including interview panels

Travel will be required, as necessary (typically less than 5%)

Qualification

Electrical engineeringMedical device developmentCircuit designAltium DesignerEmbedded systemsElectrical safety testingInnovationLeadership skillsCollaborationIntegrity