Description:
Essential Duties and Responsibilities
-
Maintain good documentation practices for all aspects of work, especially with regard to experimental work.
-
Design and layout both analog and digital circuits.
-
Analyze analog and digital circuits, including circuits containing microprocessors.
-
Maintain familiarity with all circuit components.
-
Lead and be responsible for product investigations for customer experiences associated with, but not limited to, electrical engineering items with full supporting documentation maintained throughout.
-
Support research and development by leading EE projects and activities, responsible for all aspects of activities without limitation to engineering-specific tasks.
-
Evaluate and understand electrical circuits used in pneumatic Driver systems.
-
Create and revise requirement and component specifications in accordance with established design- and document control procedures.
-
Develop manufacturing test processes by designing and modifying equipment for product verification and final acceptance testing while maintaining full supporting documentation throughout.
-
Assure electrical system and product quality by designing and documenting testing methods and supporting execution thereof.
-
Prepare product reports by collecting, analyzing, and summarizing information and trends associated with electrical characteristics.
-
Provide engineering information by answering questions and requests in a complete and concise manner and authoring supporting documentation as applicable.
-
Maintain product and company reputation by ensuring compliance with applicable regulations.
-
Maintain system and product electrical schematics and printed circuit board assembly drawings as well as all supporting and associated documentation (e.g., DCRs, BOMs, design descriptions, work instructions, etc.).
-
Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.
-
Actively participate in new product transfer into manufacturing and ensure the team achieves engineering and quality documentation requirements.
-
Research and champion an understanding of regulatory requirements as related to electrical engineering for SynCardia products.
-
Participate in related company projects to gain a solid working understanding of SynCardia business and quality systems.
-
All other duties as assigned.
Responsibility and Authority Affecting Quality
-
Act to prevent nonconformities relating to the product, process, and Quality System.
-
Identify and record potential problems relating to the product, process and Quality System.
-
Initiate, recommend, or provide solutions through designated channels.
-
Record and/or report all instances of customer feedback on product.
.
Requirements:
Skills and Abilities (Required for the Job)
-
Electrical system analysis
-
Troubleshooting analog, power, and digital circuits, to the component level
-
Effective technical information presenting
-
Excellent documentation practices
-
Excellent communication skills
-
Excellent writing skills
-
Strong organizational skills
-
Detail-orientation
-
Ability to handle multiple tasks simultaneously and to learn quickly in a dynamic environment
-
Understanding of root-cause failure investigation methods
-
Strong professional ethics and team unity
-
Experience with product validation, failure modes effects analysis, and test system architecture
-
Experience with embedded microprocessor-based systems hardware and firmware (understanding of fundamentals of assembly language, familiarity with C); LabVIEW is a plus
-
Experience with motor systems design and implementation
-
Experience with schematic and layout capture (EDA) software, e.g., Altium or OrCad
-
Understanding of the use and limitations of test equipment including oscilloscopes, multimeters, current probes, and other similar equipment
-
Able to develop diagnostic methods and tools required to improve troubleshooting and repair
-
Design of lithium-ion polymer battery subsystems is a plus
-
Experience with remote programming and control of test equipment and with development of test fixtures is a plus
Education, experience and training (Required for the Job)
-
BS in Electrical Engineering and 10+ years of industry experience, with 2+ years of medical device or other regulated industry experience -OR-
-
BS in Electrical Engineering and MS in Engineering and 8+ years of industry experience, with 2+ years of medical device or other regulated industry experience
Working environment
-
Work Station Area: Office, Laboratory
Special Factors in the Work Area:
-
Occasionally required to: stand, climb, balance, bend, stoop, kneel or crawl, work near moving mechanical parts, be exposed to extreme heat or cold (non-weather), or lift and/or move more than 25 pounds
-
Frequently required: to walk, sit, utilize hand and finger dexterity, talk, or hear
-
The noise level in the work environment is occasionally moderate.
Skills and Abilities
-
Electrical system analysis
-
Troubleshooting analog, power, and digital circuits, to the component level
-
Effective technical information presenting
-
Excellent documentation practices
-
Excellent communication skills
-
Excellent writing skills
-
Strong organizational skills
-
Detail-orientation
-
Ability to handle multiple tasks simultaneously and to learn quickly in a dynamic environment
-
Understanding of root-cause failure investigation methods
-
Strong professional ethics and team unity
-
Experience with product validation, failure modes effects analysis, and test system architecture
-
Experience with embedded microprocessor-based systems hardware and firmware (understanding of fundamentals of assembly language, familiarity with C); LabVIEW is a plus
-
Experience with motor systems design and implementation
-
Experience with schematic and layout capture (EDA) software, e.g., Altium or OrCad
-
Understanding of the use and limitations of test equipment including oscilloscopes, multimeters, current probes, and other similar equipment
-
Able to develop diagnostic methods and tools required to improve troubleshooting and repair
-
Design of lithium-ion polymer battery subsystems is a plus
-
Experience with remote programming and control of test equipment and with development of test fixtures is a plus