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Electrical Engineering Specialist
2 months ago
The Electrical Engineer will be responsible for designing, testing, and documenting electrical/electronic designs, following the Company's ISO 13485:2016 Quality Management System. This includes resolving electrical/electronic issues to meet component and system specifications, determining and facilitating third-party certifications of all electrical aspects of the Company's electromedical devices, and providing technical leadership with many aspects of the overall design of the Company's products.
Key Responsibilities- Participate in the generation of electromedical device Subsystem requirements and specifications
- Carry out electrical/electronic engineering design activities, including design, debug, modifications, and verification of electrical components of the product
- Develop manufacturing testers and test procedures
- Create the BOM for electrical assemblies and printed circuits
- Develop and document circuit schematics
- Support the layout of printed circuits
- Participate in or lead design reviews by providing expertise in hardware designs, reviewing existing designs or new designs developed by peers or external contractors
- Develop and maintain Hardware Language designs for Programmable Logic devices
- Lead hardware improvement projects as required by the business
- Follow Sterling PDLC and Design Control and Change Procedures and maintenance of Design History Files
- Develop test methods to qualify the products by working with test laboratories/agencies or in-house
- Ensure the device's electrical safety and participate in risk management activities
- Support prototype and product manufacturing activities as needed
- Investigate product complaints, perform root cause analysis of failures, and propose remediation in a timely fashion
- Responsibility for preparing all test-related equipment necessary for conducting tests and validations as needed
- Bachelor's degree in electrical engineering or a related field. A master's degree is preferred but not mandatory
- Minimum of 5 years of experience in electrical engineering, preferably in product design and development in the medical device industry, & 2+ in technical leadership position
- Sound knowledge of electronics engineering design principles for analog, digital, signal processing, power electronics, and RF designs
- Proven track record of working on projects for system integration, software/firmware development is an asset
- In-depth knowledge of relevant industry standards and regulatory requirements (e.g., IEC –, IEC, National/International Product Certification, and Design and testing for EMC; Medical Product Risk Management (ISO 14971:2019)
- Proficiency in electrical design software such as AutoCAD Electrical, Altium Designer, OrCAD, or similar tools
- Strong knowledge of circuit design, schematic capture, and PCB layout
- Experience with simulation and analysis tools like SPICE, MATLAB, or similar
- Familiarity with embedded systems and microcontroller programming
- Experience with prototyping, testing, and validating designs – waterfall and V-model approaches
- Ability to develop and execute test plans to ensure product reliability and performance
- Proficiency with testing equipment such as oscilloscopes, multimeters, signal generators, and spectrum analyzers
- Experience in setting up and maintaining a test environment, including configuring and calibrating testing equipment
- Proficient in creating detailed technical documentation, including design specifications, test reports, and user manuals
- Ability to maintain accurate records of design changes and updates – familiar with ISO 13485 design and development documentation requirements
- Demonstrate high degree of innovation to achieve high quality, usefulness, and cost-effectiveness
- Strong analytical and problem-solving skills with the ability to diagnose and address technical issues efficiently
- Strong organizational skills and attention to detail
- Able to work well in teams and independently
- Excellent written and verbal technical communications skills