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[Electrical Engineer] Electrical Engineer in MA

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NOTE: This position is set to run for 6 months to start, however it has the potential to extend or convert to Full Time based on performance and department budget

Looking for an experienced Electrical Engineer/Sr. Electrical Engineer to join the team. Candidates MUST have previous experience working in an R&D Environment or they will not be a fit for this role. They do not have to have experience in Medical Devices, however it will certainly be helpful. The chosen Candidate will be part of an enthusiastic, dynamic, results-oriented team of mechanical and electrical development engineers, and interface directly with software development engineers, scientists, and product managers working to define and develop client’s best-in-class Skeletal division products. The ideal candidate is one who understands complex electro-mechanical subsystems, and how they interact with software, manufacturing, service, and external vendors, to fulfill product requirements.

The chosen Candidate MUST have strong experience with PCB Layouts and Circuitry Design or they will not be a fit for this role!

Responsibilities:

• Create and manage product electro/ mechanical subsystem architecture, requirements, and design specifications.
• Directs activities to ensure that manufacturing, construction and operational testing conform to functional specifications and customer requirements.
• Uses computer assisted engineering and design software to perform engineering tasks.
• Lead technical development team, as required.
• Produce DHF documentation in support of design projects.
• Complete design documentation and Engineering Change Orders, as required by clients standard operating procedures.
• Interpret system requirements and decompose to develop subsystem requirements
• Drive and maintain traceability between system requirements and subsystem requirements
• Hold subsystem requirements reviews with internal and external stakeholders (suppliers) as required
• Interface with V&V to ensure requirements testability; drive defect resolutions pertaining to subsystem requirements
• Develop and maintain component or high level assembly purchasing specifications ensuring requirements are well defined, and suppliers can fulfill and test to the specifications
• Propose alternative subsystem concepts in collaboration with the lead electrical, mechanical and software engineers, to meet product definitions and evaluate based on risk, product cost, performance, safety, and reliability considerations
• Ensure that design implementation, test, and maintenance methods and processes are developed and executed in a manner that supports quality standards, whether designed in-house, or utilizing suppliers
• Performs a wide variety of complex technical tasks to assist design engineers with developmental operations.
• Create and/or participate in developing Design Requirement Documents, Design Verifications, Work Procedures and Test Procedures.
• Facilitate Design Transfer to Manufacturing.
• Work in FDA/ISO/MDD regulated environment.
• Ensures design, fabrication, maintenance and repair methods/processes are developed as well as executed in a manner, which supports all clients quality standards.
• Primary troubleshooter for project, at system and sub-system level.
• Recognizes and reports problems affecting successful completion of project, is instrumental in suggesting or effecting solution.
• Significant technical contributor to generation of specifications and schedules.
• Manages outside resources, as required.


Qualifications:

• Bachelor Degree in Electrical Engineering
• Master’s degree in Engineering, a plus
• A minimum 5 years’ experience designing and developing complex electro-mechanical medical devices or equivalent.
• 10 years of experience in systems engineering in a medical device or other regulated field
• Must be able to repetitively lift and carry product weighing approximately 30 lbs.
• Strong background in Electrical design in Analog design and Digital design.
• Orcad Schematic Capture a plus
• Knowledge of electrical compliance standards.
• Knowledge of design controls a must.
• Ability to understand interactions among components in a complex system and how they affect system performance
• Ability to understand the capabilities and limitations of electrical, and mechanical engineering disciplines and to allocate requirements among them for optimum results, while satisfying interface requirements from other engineering and functional disciplines
• Ability to transform physical and mathematical concepts into sound engineering designs
• Proficient with systems engineering methodologies and tools
• Proficient with physical and mathematical modeling tools
• Familiar with international standards on medical or other electronic devices
• In-depth understanding of all technical aspects of project at a sub-system level, with strong understanding of system level interface requirements.
• Familiar with FDA QSR and ISO 13485 design control requirements.
• Proficiency with Microsoft Office.


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