Lead Hardware Engineer

Storm3 - Houston, TX

Full-time - Senior

Houston, TX

About the position

The Lead Hardware Engineer will oversee the development of hardware and embedded/firmware software for electronic medical devices in a MedTech startup focused on transforming home-based healthcare. This role is crucial for ensuring timely and high-quality product development, including the design, testing, and mass manufacturing of PCBs, while collaborating with cross-functional teams and managing supplier relationships.

Responsibilities

• 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.
• 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.
• Build and maintain strong relationships with overseas contract manufacturers.
• Monitor performance, address issues, and negotiate contracts to ensure on-time and cost-effective production.
• Prepare and maintain comprehensive product documentation, including specifications, test plans, and reports.

Requirements

• 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

Nice-to-haves

• 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