Somerset / permanent / £45,000 - £70,000
Your new company
An international molecular diagnostics organisation operating across the US and Europe, supplying to healthcare systems and corporate partners. 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 will be responsible for developing engineering solutions for the existing product range and for new products. They will drive and oversee investigation and development activities and provide device integration engineering services to research areas including selection, acquisition and technical problem-solving. Responsibilities include:
• Provide technical expertise at the system level to align technical teams on hardware, and supply components.
• Define scope of verification testing and provide key support for verification and complete testing protocols.
• Lead quality improvement activities and suggests innovative solutions to technical problems.
• Maintain an overview of all technical aspects of the platform including firmware, software and system interfaces.
• Assess existing system architecture and recommend any enhancements or improvements.
• Plan and lead new hardware developments and steer requirements for software developments on the platform.
• Prepare documents for and support regulatory submissions
• Troubleshoot and investigate errors and faults, lead root cause analysis and plan remedial actions.
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 a growing diagnostics company that respects and looks after their employees. You are rewarded with a highly competitive salary with additional health benefits. They offer an attractive annual leave package and flexible working arrangements.
Contact Keystream to find out more about the role and apply. The role requires a prompt start.
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.