Job Details

Electrical EngineerDexis
Job Start Date:4/6/2022Type of Position:Full Time
Number of Openings:1
Job Location & Contact:
2800 Crystal Drive
Hatfield, PA19444
5551212
Email
Job Description:
Overall responsibility for ensuring that products are developed and tested in compliance with all applicable agency and market requirements. Additional responsibility for the design/development and sustainment of electric/electronic circuits for products in the Dental Industry ensuring timely delivery of electrical engineering deliverables, meeting performance and cost specifications for all new product development, sustaining, and value engineering activities. Understand medical device safety standards (IEC/UL/ES 60601-1) and regulatory requirements and be capable of identifying those that are applicable for each unique project. Obtain product certification/recognition to applicable EN, ISO & IEC 60601-1general, collateral, and particular standards through regulatory agencies. Provide Engineering support to Regulatory Affairs to facilitate international product registration and 510K submissions Familiarity with the construction / architecture of product Technical Files, DHF, DMR, and DHR. Interface with Safety Agencies (ETL, UL, CSA, etc.) to coordinate RFQs and work package(s) and providing technical guidance / support during product certification. Provide Support to RA / QA teams as Engineering Team liaison during FDA, Certification Agency, and ISO audits. Address non-compliance issues / audit findings, owning and driving closure of the findings. Understand CAPA Process and lead through completion any assigned Participate in and provide guidance for design reviews, FMEA, Risk Analysis and Usability Engineering activities. Contribute toward the maintenance of accurate and organized safety files and compliance related documentation per Design Control operating procedures and related work instructions. Provide guidance for label design and content to meet regulatory requirements Provide compliance content and guidance to technical writers for accompanying documentation and instructions for use, including EMC compliance content Write and maintain work instructions and create templates for compliance processes (e.g. Risk Management, Usability Engineering) Participate in Kaizen’s Provide input to project scheduling and management to complete compliance related tasks Assist with EMC Test Plan, evaluation, and mitigation. Lead and manage compliance projects Assure compliance to Biocompatibility and restricted substance requirements, leading and managing associated projects. Ability to read schematics and debug circuitry (analog, digital, power). Design / testing / validating / documentation of new and sustaining products. Analog Circuit Design Experience Digital Circuit Design Experience Power Conversion Design Experience System Level Design Experience Firmware/Software Design Experience Set up experiments and take & analyze data. -Analyze if Circuits are performing to spec. -Analyze if Firmware/Software is meeting spec. -Analyze PCB layout for signal integrity and proper performance. -Analyze Components for thermal considerations. Design/Construct Test Fixtures. Assist in Cable Design and prototype builds. Create work instructions, test reports. Works independently, with minimal direction from contributing engineers. Other duties as assigned
Experience Required:
Minimum Qualifications: B.S. degree or equivalent in Electrical/Electronic Engineering Technology, Computer Engineering Technology, or Biomedical Engineering. 2 + years’ experience in the design / testing and analysis in electronic circuitPreferred Qualifications: Familiarity with IEC/UL/ES 60601-1 -Ability to read schematics and test PCBs. -Ability to work with oscilloscopes, logic analyzers, spectrum analyzers, DMMs, power supplies. -Ability to set up and document experiments for new or sustaining projects. -Ability to program in C and Python -Working knowledge of Office, Spice, Visio. -Knowledge of Analog / Digital Circuits Excellent communication skills required (written and verbal). Medical Instrumentation experience a plus. M.S. degree preferred. Compliance Engineering experience a plus. Power Supply Testing Experience. Analog/Digital/Power Conversion circuit design. Schematic Capture and the design of PCBs using CAD software (experience with Altium highly desirable). Contributes to cross-functional problem solving. 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
How to Apply:
Visit our website at https://careers.envistaco.com/
Application Deadline:
Jan 01, 1900
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