Senior Systems Engineer needed at leading medical device company located in Los Gatos, CA. Must have electrical systems engineering experience within medical device product development environment. APPLY NOW!!!
- 3+ years of experience as Electrical Systems Engineer with medical device product development
- Hands-on engineering skills and experience with bench testing and troubleshooting
- Experienced with requirements management software, e.g. JAMA preferred
- Experience with software programming to develop test environments and fixtures
location: LOS GATOS, California
job type: Permanent
salary: $100,000 - 150,000 per year
work hours: 8am to 4pm
- Create and manage product requirements and engineering specifications, and generate test plans and protocols during the life cycle of the product development
- Research, identify and apply relevant medical development standards, such as IEC 60601, IEC 62304, ISO 14708, etc. towards product requirements, risk management and test plans
- Generate test plans and protocols for characterization and verification, and develop new test methods and fixtures
- Lead and perform system, sub-system and component level characterization and functional testing, and coordinate compliance testing at external test labs
- Perform design analysis and conduct regular design reviews with hardware and software teams
- Collaborate with program managers to create and manage development plans and project plans related to electronic and software systems development
- Lead and contribute in creation of risk management documentation, including FMEAs
- Develop and maintain documentation (e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files. Manage and assist in creation of ¬manufacturing process instructions, bills of material, quality inspection, and related documentation
- Experience level: Experienced
- Minimum 3 years of experience
- Education: Bachelors
- Systems Engineer
- Medical Device
- Product Development
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.