Description

Lead EE hardware + embedded/firmware software development for electronic medical devices. Development of electronic hardware for on time and quality delivery. Design, build and test PCBs for different projects. Ability to program and troubleshoot embedded/firmware software. Source components and work with local and overseas suppliers. Complete product development including technical specifications, development, testing and design for production. Ability to design PCBs for mass manufacturing in cooperation with our manufacturing partners.

Responsibilities

- EE Product Development: Collaborate with cross-functional teams, including design, software, mechanical and manufacturing, to develop new products or improve existing ones. Apply your electrical engineering background to provide valuable insights into product design and functionality.

- Quality Assurance: Implement and maintain ISO13485 and IEC61010 or IEC60601 standards in all phases of product development and production. Conduct risk assessments and quality control processes to ensure compliance with regulatory requirements.

- Supplier Management: Build and maintain strong relationships with overseas contract manufacturers. Monitor their performance, address issues, and negotiate contracts to ensure on-time and cost-effective production.

- Documentation: Prepare and maintain comprehensive product documentation, including specifications, test plans, and reports. Ensure all documentation meets regulatory and quality standards.

Qualifications

- College degree in Engineering or a related field

- 10+ years of industry experience in EE product design, development and manufacturing

- Proven experience in product management, preferably in the medical device or heavy regulated industry

- Strong knowledge of ISO13485 and IEC61010 or IEC60601 standards and their practical implementation

- Familiarity with Nordic Semiconductor nRF52 and nRF91 chips and Nordic nRF SDK + Zephyr RTOS

- Familiarity with wireless communication over Bluetooth Low Energy and Cellular/LTE

- Excellent project management skills, including the ability to lead cross-functional teams.

- Strong analytical and problem-solving abilities.

- Excellent communication and interpersonal skills.

- Experience working with international contract manufacturers is a plus.

- Familiarity with regulatory requirements to import and export goods in the international market is a plus

- Experience designing products conforming to IP66/67/68 is a plus

Ability to travel as needed (domestic and international).