Electrical/Test Engineer, GNV

Position Overview:

This is an electrical engineering position responsible for supporting early-stage feasibility and product development of low power battery-operated medical devices electronics. This position must have a good understanding of both analog and digital circuit design, and experience with functional/electrical test applications. The candidate will interface with R&D electrical engineers to develop new and modify existing test processes, programs, and fixtures. This position requires close cooperation with other members of the electrical engineering team to accomplish project objectives. It also requires interaction with outside contract design houses and vendors, manufacturing, software, mechanical, and quality groups. This individual will be reporting directly to the Director of Manufacturing Engineering.

Responsibilities:

• Responsible for supporting early-stage feasibility and product development of low power battery-operated devices used to administer insulin to diabetes patients.

• Participate in generating design requirements, prototyping, and design implementation.

• Interface with R&D electrical engineers to develop new and modify existing test processes, programs, and fixtures.

• Responsible for conducting design reviews, design verification, and design documentation, in accordance with FDA design control guidelines.

• Responsible for generating test requirement matrix and procedures to test design input requirements.

• Responsible for identifying test methods and developing test fixtures for the purpose of design verification test cases.

• Participate in cross-functional meetings to review design, manufacturing procedures, or quality-related issues.

• Apply principles and techniques of electrical engineering to analyze failures to improve design or manufacturing processes.

• Participate in human factor/usability and design validation processes.

• Participate in risk management analysis and documentation.

• Responsible for design modification, new component qualification, design change test requirements, and design change documentation.

• Perform other duties as required.

Minimum Required Education and Experience:
High School diploma and 10+ years of practical experience in Engineering within a highly regulated manufacturing environment; preferably in the medical device industry.
OR
BS. in Mechanical/Industrial/Electrical Engineering and 6+ years of experience in a highly regulated manufacturing environment; preferably in the medical device industry.

OR
MS. in Mechanical/Industrial/Electrical or Engineering Management with 5+ years of experience in a highly regulated manufacturing environment; preferably in the medical device industry.

Preferred Skills and Competencies:
• Demonstrated working knowledge of electrical engineering (both analog and digital).
• Demonstrated working knowledge of low power embedded design.
• Demonstrated working knowledge of Computer Aided Design.
• Demonstrated working knowledge of tools and instruments utilized in electrical engineering field.
• Working knowledge of LabVIEW tools is a plus.
• Familiarity with FDA guidelines on design and manufacturing of the medical devices is a plus.
• Knowledge of RF Design and BLE protocol is a plus.
• Effective verbal and written communication skills.
• Ability to communicate at multiple levels of an organization.
• Ability to organize and judge priorities.
• Ability to manage projects.
• Knowledge of analog and power supply design.
• Knowledge of digital circuit design and Microprocessors.
• Knowledge of low power battery operating embedded system.
• Knowledge of PCB layout design rules.
• Familiarity with the RF design and BLE protocol is a plus.
• Ability to use laboratory equipment for electronics measurement.
• Knowledge of National Instruments LabVIEW tool is a plus.
• Knowledge of electrical safety and EMC standards for medical devices is a plus.
• Knowledge of FDA design control guidelines is a plus.

Physical Requirements:
• This position may require business travel.

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite

Additional Information:

The US base salary range for this full-time position is $84,525.00 - $126,787.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work