SUMMARY

The Electrical Engineer I, Sustaining, will serve as a valuable member of the Engineering team for sustaining existing medical devices and accessories, and supporting the design of new products. This includes product design, supporting manufacturing planning and launch, maintaining engineering documents (BOMs, drawings, specifications, schematics, etc.), and implementing design improvements and modifications after product launch.    

PRIMARY RESPONSIBILITIES

• Investigate complaints, note trends, and implement product improvements.
• Partner with Quality Assurance associates to support the resolution of product issues (including NC and CAPA support).
• Support design efforts to sustain existing products and drive product improvements under the guidance of senior engineers and project managers.
• Support and contribute to the maintenance of existing product Design History Files (DHF) and the creation of product Device Master Records (DMR).
• Support Product Development in the development of product design input requirements, specifications, generating design concepts, prototype builds, testing, and transferring to manufacturing.
• Contribute to electrical analysis and establishment of test plans to demonstrate products meet all requirements.
• Contribute to project team activities as assigned.
• Support product development efforts by developing circuits to implement design requirements and/or creating electrical schematics.
• Support the development and qualification of production test fixtures for PCBAs and other electrical components under the guidance of senior engineers and project managers.  
• Support qualification of suppliers for electrical components.
• Perform other related duties as assigned.

KNOWLEDGE AND SKILL REQUIREMENTS

• A bachelor’s degree in electrical engineering or a related engineering field is required.
• 0-2 years of experience in design/sustaining engineering, preferably in the medical device industry.
• Knowledge of medical device development, design transfer, design for manufacturability (DFM), reliability and cost.
• Familiar with medical device DHF and DMR files management and documentation requirements.
• Knowledge of component design, manufacturing, electrical component selection, and testing of equipment is preferred.
• Knowledge of manufacturing processes typical of medical devices, including manual assembly, semi-automated assembly, and automated SMT processes.
• Excellent organizational, interpersonal, oral, and written communications skills.

WORKING CONDITIONS

• Ability and willingness to “get the job done”, allowing for flexible and extended hours, depending on project need.  
• Remote or Small office environment, electrical and mechanical prototyping labs.
• Ability to effectively work in a “virtual environment” at home or at a centrally located office.  
• Periodic travel, such as supplier visits, can usually be planned in advance.