Medical Device Engineering Manager

Under close supervision, coordinate product development lifecycle of Company platform including concept, requirements, development, verification and validation, and manufacturing transfer. Under close supervision, coordinate medical device products through a development cycle and deliver on time and within budget. Adherence to FDA regulations on medical device product development, design controls, manufacturing, and project management. Assist with the product roadmap, create and coordinate timelines/risks across research and development teams. Under close supervision, coordinate across groups to manage schedules and budget for engineering, software, manufacturing, clinical, quality, and regulatory deliverables for successful 510(k) approval and launch. Assist in ensuring design control processes are strictly adhered, and each stage is completed per quality and process guidelines. External contract manufacturers and vendors point-of-contact.

Position permits telecommuting from the U.S.

Required education: Master of Science or equivalent in electrical engineering or related field.

Required experience: 12 months as Systems Engineer or related.

Additional minimum requirements: work experience to include at least 1 year of the following:

1. Product timeline management for a class II/III medical device product launch with external and internal teams;
2. Verification, integration, and validation of system and sub-system components;
3. FDA design controls including 21 CFR820, risk management, hazard analysis, mitigation strategy, FMEAs, IEC 62366- human factors and quality management system including ISO 13485 and ISO 62304;
4. Defining user needs along with system and subsystem architecture, system requirements, and testing.

40 hours/ week. Job site/ interview: Fremont, CA. Salary $182,645/ year. EOE