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You will be updated with latest job alerts via emailWe 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 crossfunctional 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 uptodate with industry trends and developments and incorporate new technologies and best practices into product development
Qualifications:
Bachelors 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 crossfunctional teams
Strong analytical and problemsolving 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
Full Time