Job Description
Works with and across the various disciplines of the engineering team, machine shop personnel, and assembly floor personnel for project realization, manufacturability, inspection, and assembly of product. One of the primary functions of the position is to create and develop designs that meet product specifications and requirements of our customers whether internal or external.
JOB DUTIES:
· Provides technical support to Management, Business Development, Engineering, Manufacturing, QA/RA, and Purchasing as needed or when requested.
· Creates and develops designs from customer requirements to proof of concept to fully actualized and commercialized products.
· Evaluates and troubleshoots problems, issues, or challenges in the design that may affect performance, manufacturing, inspection, and assembly processes to provide solutions.
· Must be able to perform and demonstrate all developed and existing manufacturing, inspection, and assembly processes in a general hands-on approach.
· Gathers information for analysis to provide data on existing as well as proposed manufacturing, inspection, and assembly processes for good decision making. This may include calculating production costs through labor, methods/processes, time, equipment, and materials.
· Works and collaborates with outside suppliers in acquiring information for new development requirements or in working through problems, issues, and/or challenges.
· Complies with regulations and established company policies, procedures, and processes to ensure best practices are followed that ensure all products or processes meet specifications and/or requirements.
REQUIRED
· BS in Electrical Engineering or related field is required.
· 5 years of related industry experience is required.
· Design and development in regulated industries required, preferably medical device background and working knowledge of IEC 60601-x, ISO 13485.
· Candidates must be familiar with ISO9001 requirements and Compliance Testing Requirements (IEC / EN, UL, CSA, and TUV).
· Hands on experience with analog/digital circuits, electrical-mechanical drivers.
· Proficient in Electronics (mixed-signal, analog and digital) design, simulation, and testing.
· PCB layout and schematic working experience required (Orcad suite experience preferred).
PREFFERED
· Experience in medical device process design and development.
· Ability to design electronics to withstand harsh medical device cleaning and sterilization environments.
· Design and development of electromechanical systems, which include motors, cables, batteries, BLDC motor controller.
· Proficiency in schematic design, layout & programmable logic (FPGA/CPLD).
· Experience with Power supplies, oscilloscopes, and other test equipment strongly preferred.
· Knowledge of microcontroller/microprocessor applications.
· Knowledge of high-level software languages, such as C.