The Staff Electrical Engineer applies advanced engineering and scientific principles to the evaluation and solution of technical problems within the electrophysiology medical device market. Performs technical studies in support of project goals. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Initiates the planning, organizing, performing, coordinating and/or directing of engineering work.
Researches, designs and/or leads the analog and digital hardware systems for a variety of prototype devices, tools and fixtures based on project needs Conducts evaluations, tests and analyses related to feasibility and function. Performs troubleshooting and fault isolation activities on a variety of products and prototypes. Writes technical reports and conducts presentations to document work, illustrate concepts and demonstrate progress. Conducts measurements specified in design verification plans, documents and tabulates results, and provides engineering test reports. Documents custom tools with specifications, schematics and mechanical layouts to support document control and tool release. Documents activities, including designs and design concepts, to support successful project transfers from research to product development programs. Stays informed and up to date on technological developments within the electrophysiology (EP) medical device industry and competitive environment to identify opportunities that align and support organizational strategy. Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned.
Bachelor of Science in electrical/electronic engineering or related engineering field. 8+ years of relevant analog and digital design work experience in performing the schematic capture, layout, construction, test, and evaluation of a variety of prototype Printed Circuit Assemblies, fixtures and tools. A solid understanding of high-speed signal integrity and EMI mitigation techniques. Experience with PCB schematic and layout design tools such as Altium. Demonstrated ability to develop completely new designs and new design features as part of existing systems. Demonstrated ability to learn new skills quickly and perform developed skills with a high level of quality. Documented record of identifying and delivering key engineering information which adds value to management's decision-making process. Experience working in a broader enterprise/cross-division business unit model preferred. Experience with FPGA hardware design and HDL programming such as Verilog. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in an effective manner. Strong organizational and follow-up skills, as well as attention to detail.
The Senior Electrical Engineer performs the layout, construction, and evaluation of a variety of prototype Printed Circuit Boards, fixtures, and tools. Applies advanced engineering and scientific principles to the evaluation and solution of technical problems. Initiates the planning, organizing, performing and coordinating of engineering work. Performs technical studies. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
- Leads and/or participates on engineering teams in completing development projects.
- Completes system, analog, digital, and firmware designs. This includes setting and revising requirementsA and specifications, debugging, testing electrical circuits and systems, and completing documentation to ensure feasibility and verifiability of performance.
- Plans, coordinates, and assists in executing the activities of development teams in support of project goals.
- Effectively communicates the project successes, risks, and roadblocks to the appropriate management levels.
- Identifies and mitigates project risks.
- Conceptualizes improved designs using technical expertise and innovative approaches.
- Interfaces with various internal functions, outside consultants, vendors.
- Establishes test methods
- Ensures compliance with procedural and documentation requirements of client , FDA and ISO design controls
- Supports and leads design reviews
- Solves complex and diverse technical problems by applying sound judgment, creativity, appropriate data analysis, and technical expertise.
- Bachelor's degree in Electrical Engineering
- Analog and digital design experience
- PCB design, preferably with Altium
- Experience with high voltage and high frequency design
- 7+ years of experience in medical device development
- Strong verbal and written communication skills
- Master's and/or PhD degree in Electrical Engineering
- Embedded firmware design
- Design simulation
- FPGA/VHDL design
- Previous experience in cardiac electrophysiology and/or cardiac rhythm management
- Familiarity with IEC 60601, ISO 13485 and 21 CFR 820.30 family of standards
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