My client is transforming home-based healthcare with a proactive and predictive system that identifies chronic health exacerbations early. This enables timely preventive care, improving patient outcomes and reducing costs. Their team of experienced entrepreneurs, engineers, and clinicians is developing innovative medical products that integrate hardware, software, and artificial intelligence to enhance the lives of chronic care patients through passive monitoring.
Description
My client is looking for a Lead Hardware Engineer to oversee hardware and embedded/firmware software development for electronic medical devices. The role involves ensuring the development of electronic hardware is on time and of high quality. The candidate will design, build, and test PCBs for various projects, with the ability to program and troubleshoot embedded/firmware software. They will source components and collaborate with local and overseas suppliers, overseeing complete product development, including technical specifications, testing, and design for production. The candidate will also design PCBs for mass manufacturing in cooperation with manufacturing partners.
Responsibilities
Electrical/Hardware Product Development: Collaborate with cross-functional teams, including design, software, mechanical, and manufacturing, to develop new products or improve existing ones. Utilize electrical engineering expertise to provide insights into product design and functionality.
Quality Assurance: Implement and maintain relevant standards (e.g., ISO13485, IEC61010, IEC60601) 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 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 electrical engineering product design, development, and manufacturing
Proven experience in product management, preferably in the medical device or heavily regulated industry
Strong knowledge of relevant standards and their practical implementation
Familiarity with specific semiconductor technologies and software platforms
Experience with wireless communication technologies (e.g., Bluetooth Low Energy, Cellular/LTE)
Excellent project management skills and the ability to lead cross-functional teams
Strong analytical and problem-solving abilities
Excellent communication and interpersonal skills
Experience with international contract manufacturers is a plus
Familiarity with regulatory requirements for international trade is a plus
Experience designing products conforming to specific IP ratings is a plus
Ability to travel as needed (domestic and international)