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Systems Engineer, Medical Devices

Location : Livingston NJ US 07039
Job Type : Temp/Contract to Direct
Reference Code : 20146-BZ1
Compensation : open - 45-55/h
Start Date : 03/02/2020
Hours : Full Time
Required Years of Experience : 3
Required Education : BS Electrical Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices

Job Description :

  • Contract to direct position for an Electrical Engineer to work as a Systems Engineer developing innovative solutions for medical devices.

  • Ensure on-time releases of new designs and existing product changes.

  • Generate design plans for new product offerings as well as to enhance existing products based on new business objectives.

  • Design, test, troubleshoot and document product solutions to meet FDA Design Controls and

  • other regulatory body requirements.

  • Develop schematics, PCB layouts, BOMs and complete assemblies.

  • Develop and maintain user manuals.

  • Build & test prototypes for new product development.

  • Utilize verification and validation methods to demonstrate designs meet all design requirements.

  • with particular attention given to quality and regulatory requirements.

  • Support safety testing via 3rd party test facilities.

  • Determine root cause for complex issues and develop practical, efficient, and permanent

  • technical solutions.

  • Create Production test fixtures, work instructions and provide the related training.

  • Lead process qualification efforts to verify the manufacturability and quality of products

  • released to Production (In-house & Contract Manufactured).

  • Work with Repair Technicians to ensure trouble-shooting & repair is effective & efficient.

Required Qualifications :

  • BS Electrical Engineering or related field.

  • Minimum 3 years of experience within the medical device industry with knowledge of FDA and ISO regulations.

  • Ability to prioritize effectively and work on concurrent projects.

  • Ability to make proactive and constructive suggestions for process or product improvement.

  • Strong understanding of product design requirements of 21 CFR Part 820 and ISO 13485 for compliance with US and EU regulatory requirements.

  • Capability of performing all aspects of systems engineering including: concept, architecture, block/functional diagrams, system level documentation.

  • Experienced in designing precision, low current measurement and low noise analog electronics.

  • Experienced in designing, debugging and supporting analog/digital circuits as well as real-time embedded electronics for both microprocessor-based, FPGA, CPLD and DSP hardware platforms.

  • Solid understanding of the PCB fabrication process and proficient in using schematic diagram development tools (ORCAD/PADS), PC board layout tools (ORCAD/PADS), and simulation tools (SPICE).

  • Working knowledge of fundamental PCB layout concepts especially in regards to EMC and ESD.

  • Knowledge of IEC 60601 and IEC 60601-2 standards

  • Knowledge in the C language as it pertains to embedded software development.

  • Skilled at using oscilloscopes, Logic Analyzers, and processor emulators/debuggers.

  • Proficiency with Microsoft Office Suite products, such as Word, Excel, Visio and PowerPoint.

Contact: Bill Zukowsky

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