Systems Engineer Director.
Somerset / permanent / £80,000 - £120,000
Your new company
An international molecular diagnostics organisation operating across the US and Europe, supplying to healthcare systems and corporate partners. They are currently experiencing rapid growth and seeking the right people to take their business to the next milestone, whilst retaining their incredible culture and family-feel environment.
Your new role
The Systems Engineer Director will be leading the technical engineering vision, maintaining all technical aspects for the point of care platform. Responsibilities include:
• Manage and maintain all technical aspects for the product portfolio.
• Manage existing system architecture and recommend and improvements.
• Drive system-wide troubleshooting and root cause analysis investigation across the engineering, manufacturing and R&D teams.
• Provide technical expertise throughout the company.
• Provide technical expertise at the system level to align technical teams on hardware, and supply components and drive collaboration and excellence across all areas.
• Drive, direct and lead strategy for new hardware developments and product pipeline.
• Define scope of verification testing and provide key support for verification and validation activities.
• Prepare documents for and support regulatory submissions.
• Steer software development requirements for the platform.
• Support security management process including risk and vulnerability analysis and related documentation associated with integrated devices and systems.
What you need to succeed
• Educated to degree level in relevant field – Systems Engineering, Biomedical Engineering or Chemical Engineering
• Proven experience working within the medical device or molecular engineering industry.
• Demonstrated experience with FDA QSR and ISO 13485
• Experience developing products in an IVD diagnostic development, including use of Statistics in experimental design.
• Strong understanding of mechanical, electronic and software design principles
• General understanding of molecular biology, focussed on PCR and sample preparation.
What you get in return
The opportunity to work with an inclusive, growing diagnostics company that respects and looks after their employees. You are rewarded with a highly competitive salary with additional benefits, including healthcare. They offer an attractive annual leave package and flexible working arrangements.
Apply, or contact us as soon as possible for more information.
Keystream is an equal opportunities employer, committed to increasing diversity and inclusivity. We represent values-led clients with an EDI agenda and strongly encourage applications from under-represented groups.
Please let us know if there is anything we can do to help make the recruitment process more accessible for you.