We seek a dynamic and experienced Head of Engineering to lead our team in developing portable medical diagnostic products. The ideal candidate should have a strong background in hardware product development and a good understanding of software and firmware development in a regulated environment. They should also be experienced in working with mechanical and optical systems and reviewing electronics, firmware, and software teams.
Key Responsibilities:
• Lead and manage the engineering team, ensuring that projects are completed on time and within budget
• Oversee the development of new microfluidic consumables from concept to commercialization
• Oversee the development of new generations of hardware devices with integrated firmware and software
• Work closely with cross-functional teams, including assay development, quality assurance, and business development to ensure that products meet customer needs and regulatory requirements
• Collaborate with external partners and vendors to source components and materials for product development
• Review and approve engineering designs and specifications, ensuring that they meet quality and safety standards
• Develop and maintain engineering standards and documentation procedures, ensuring compliance with regulatory requirements
• Stay up-to-date with industry trends and developments, and incorporate new technologies and best practices into product development
Qualifications:
• Bachelor's degree or greater in Engineering or a related field
• 10+ years of experience in engineering in a commercial organization, with a focus on hardware development in a regulated environment
• Experience working with mechanical and optical systems, as well as reviewing and working with firmware/software
• Strong leadership and management skills, with the ability to motivate and inspire a team
• Excellent communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams
• Strong analytical and problem-solving skills, with the ability to identify and resolve complex technical issues
• Proficiency in relevant software and tools, such as CAD, CAM, and simulation software
• Familiarity with regulatory requirements and quality management systems, such as ISO 13485 and 21 CFR Part 11
...
