Essential Responsibilities and Duties
* 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)
* Provide technical support to the Manufacturing and Service person.
Required Skills / Experience
* Bachelor of Science Degree in Electrical Engineering or related field
* Minimum 4 years of experience within the medical device industry with knowledge of FDA and ISO regulations.
* Excellent written and verbal communication skills. Strong technical writing skills.
* Detail oriented with solid organizational skills.
* Excellent analytical problem-solving skills
* Ability to prioritize effectively and work on concurrent projects.
* Ability to make proactive and constructive suggestions for process or product improvement.
* Ability to work both autonomously and in a collaborative team environment.
* Team player willing to take on assignments that are not always within core competency.
* Strong understanding of product design requirements of 21 CFR Part 820 and ISO 13485 for compliance with US and EU regulatory requirements.
* Capable of performing all aspects of systems engineering including concept development, architecture design and 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.