Sr. Engineer, Electrical

Gener8, LLC•San Jose, CA

97d•$104,408 - $174,013

About The Position

Gener8 is hiring a Sr. Engineer, Electrical to work on its engineering team in San Jose, California. The role focuses on current and next-generation medical instrument designs and supporting product development in a dynamic, collaborative environment. The team emphasizes open communication, empowerment, innovation, teamwork, and customer success. The engineer will contribute to product development and improvement, conduct bench and preclinical studies, prepare test documentation, support design reviews and risk management, and independently plan and execute work toward project goals. The role also requires understanding and complying with applicable FDA, ISO, and other quality and regulatory requirements. Gener8 provides engineering design services and manufactures complex instruments, software, and consumables for customers developing research instruments and medical diagnostic and surgical devices.

Requirements

At least 4 years of experience in design, testing, manufacturing, or other engineering support, and medical device experience.
Experience working with cross-functional teams.
Experience owning and driving deliverables as a team member and individual contributor in a fast-paced, changing environment.
Proficiency collaborating with project stakeholders, including clients, internal stakeholders, end users, business partners, and technical team members.
Strong organizational and follow-up skills, with attention to detail.
Strong verbal and written communication skills, including the ability to communicate effectively at all organizational levels.
Ability to distill complex topics into easily digestible content and highlight key points.
Experience in design, modeling and simulation, and physical prototyping.
Circuit design aptitude, including translating requirements into circuit designs or specifications.
Modeling and simulation experience in circuit and free-space domains.
Proficiency with Comsol, Ansys, HFSS, CST, or similar packages for creating designs and debugging issues.
Demonstrated initiative in going beyond assigned tasks independently.
Critical-thinking ability to address design challenges.
Ability to plan, execute, analyze, and document individual scientific studies.
Ability to collect, organize, and analyze data using statistical methods.
Bachelor’s degree in Electrical Engineering or Physics, or equivalent experience.

Responsibilities

Contribute to a team committed to delivering the next generation of products.
Drive the continued transformation of capabilities, equipment, and facilities.
Conduct bench and preclinical studies supporting product development teams for concept feasibility and formal regulatory submission.
Contribute to the continuous improvement of electronic designs.
Draft test protocols and reports.
Independently plan, coordinate, and execute activities in support of project goals.
Conduct design reviews.
Support development of risk management documentation.
Gain an understanding of quality and regulatory requirements, including FDA and ISO regulations.
Comply with FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintain positive and cooperative communication and collaboration with employees, customers, contractors, and vendors at all levels.
Perform other related duties and responsibilities as assigned.