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DEXIS · 1 day ago

Electrical Engineer (Hybrid-Quakertown, PA)

Quakertown, PA

Full-time

Hybrid

Mid Level

$79K/yr - $109K/yr

3+ years exp

DEXIS is the leading manufacturer and distributor of innovative dental imaging equipment, software, and solutions. The Electrical Engineer is responsible for ensuring that products are designed, developed, tested, and sustained in compliance with all applicable agency and market requirements.

Health CareManufacturingMedical Device

Responsibilities

Ensures timely completion of electrical engineering deliverables, such component selection, schematic capture, PCB layout, testing, etc

Ensures all devices (new product and existing product changes) meet compliance, performance, and cost specifications

Generates applicable QMS (quality management system) documentation such as theory of operation, formal design reviews, formal test reports as well as contributing content to user manuals

Provides input to project scheduling and management

Participates in and provides guidance for design reviews, FMEA, Risk Analysis and Usability Engineering activities

Contributes to QMS procedure maintenance as applicable

Obtains product certification/recognition to applicable EN, ISO & IEC 60601-1 general, collateral, and standards through 3rd party compliance laboratories (UL, ETL, TUV, BSI, etc.)

Qualification

Electrical EngineeringCompliance EngineeringAnalog/Digital Circuit DesignPCB DesignMedical Device ExperienceFMEARisk AnalysisISO 13485Firmware DesignC ProgrammingPython ProgrammingCommunicationTeam CollaborationProblem Solving

Required

B.S. degree or equivalent in Electrical/Electronic Engineering Technology, Computer Engineering Technology, or Biomedical Engineering

3+ years' experience in the design / testing and analysis in electronic circuits

Basic understanding of device safety standard, IEC 60601-1 preferred

Working knowledge of analog / digital circuits

Experience with developing design documentation including formal test reports; participating in FMEA and design reviews

Excellent communication skills (written and verbal)

Ability to work independently and with a cross functional team

Occasional Travel: Up to 10%, as needed

Preferred

M.S. degree preferred

Medical device design and compliance experience

Compliance Engineering: Performed GAP assessment, i.e. analyze product design and documentation vs. applicable standards and/or updates to standards

Lead projects with 3rd party compliance laboratories (UL, ETL, TUV, BSI, etc.)

Has developed EMC test plans

Analog/Digital/Power Conversion circuit design

Schematic Capture and the design of PCBs using CAD software (experience with Altium highly desirable)

Has analyzed schematics; test & trouble shoot PCB to component level; works with oscilloscopes, logic analyzers, spectrum analyzers, DMMs

Has simulation tool experience

Has firmware and software design experience with the ability to program in C and Python

Has developed EMC Test Plans, conducted EMC evaluations, and EMC noncompliance mitigations

Has developed system interconnect solutions i.e., cabling/wiring

Contributed to cross-functional problem solving

Collaboration with cross functional teams: mechanical engineering, software engineering, quality engineering, regulatory affairs

Has developed FMEA, Risk Analysis and Usability Engineering documentation (ISO 14971 highly desirable)

Experience with FDA 510K cleared medical devices and has contributed to 510K submissions

Experience with ISO quality management systems and processes (ISO 13485 highly desirable)

Designed and lead construction of test fixtures

Fundamental understanding of: Design for Manufacturing, Sourcing, Assembly, Reliability Principles, Human Factors and Usability Engineering Considerations, Risk Analysis and Mitigation, Component selection, Value Engineering principles