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