SUMMARY OF POSITION
- The candidate will be a key technical contributor in the product development and analysis of variety of electromechanical and electrical medical devices.
- The candidate will be an integral member of a talented and diverse product development team which will not only be creating innovative products and taking them from early concept through commercialization but will also be responsible for back end maintenance of products post launch.
- This candidate will participate in designing, prototyping, and testing of electrical and electromechanical systems and sub systems. The candidate will be required to provide reliable solutions using the latest ECAD tools for simulation and prototyping of both analog and digital circuits including test bench development.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Broad knowledge of digital and analog electrical engineering concepts is required.
- Design, evaluate and troubleshoot electronic circuits and components for electromechanical medical systems.
- Knowledge of EMC design techniques and standards (IEC60601).
- Knowledge of board level design techniques to ensure signal integrity in low voltage high-speed applications.
- Knowledge with PCB layout and firmware design processes including requirements management, documentation and verification testing.
- Perform Risk and Failure analysis of electronic components and software
- Knowledge of PC drivers, DOS and Windows Based PC repair and troubleshooting.
- Knowledge of ISA bus and GPIB communications.
- Knowledge of C programming.
- Knowledge of standard engineering laboratory procedures.
- Knowledge of Restriction of Hazardous Substances Directive or RoHS
- Ability to apply appropriate standards, processes, policies, procedures, practices and tools throughout the product/system development lifecycle, including Standard Operating Procedures (SOP's), and applicable medical device development protocols under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems
- Ability to carry out engineering calculations and analysis.
- Ability to write engineering documents, test protocols, laboratory notebook entries and reports.
- Ability to perform component engineering design and changes.
- Ability to operate laboratory instruments.
- Actively participate in product transfer to production, including sustaining engineering
- Effective oral and written communication skills
EXPERIENCE
- 7+ Experience in development of complex medical products from concept to commercialization desired under FDA Quality System Regulations, CE Marking and ISO Quality Systems is desirable
KNOWLEDGE, SKILL, AND ABILITY
- Action Oriented
- Dealing with Ambiguity
- Approachability
- Boss Relationships
- Composure
- Creativity
- Timely Decision Making
- Decision Quality
- Functional/Technical Skills
- Informing
- Intellectual Horsepower
- Learning On The Fly
- Listening
- Organizing
- Perseverance
- Presentation Skills
- Priority SettingRoles and Responsibilities