We are looking for professionals experienced in working with surgical cameras, scopes and displays. You will work closely with the biomedical and surgical staff to ensure proper function of cameras and scopes, and troubleshoot to assist with our technicians in identifying problems with handling or cleaning. This is a full-time, W-2 position with benefits and overtime. The location is a level-1 trauma hospital with a separate pediatric department. Applicants must have a high level of comfort to start, as training will be fast-paced. We need a self-motivated and detail-oriented worker who will communicate clearly and frequently with our company repair team and clinical education staff, as well as work seamlessly within the OR to foster strong relationships with surgeons and staff.

Your new role The Reagents Specialist will be responsible for the management of the assay formulated reagent designs throughout development, transfer to manufacture and scale up. Management of the assay reagent designs and handling studies and aiding QC test method development, implementation, and risk management for effective manufacture. Support R&D, QC and Operation departments to meet corporate goals. Leading standardised chemical formulation calculations and being the authority on applied chemistry principles within the business, acting as a mentor to the team.     Working collaboratively with both internal and external parties to ensure high level critical to quality control of the formulated reagents both at R&D, Commercial manufacture and scale up. Authority figure in applied chemistry principles and their application, particularly around formulation and chemical calculations. Reagent and chemical safety, risk management and regulatory oversight Maintaining the QMS and company compliance to ISO13485 / 21 CFR Part 820 level What you need to succeed Educated to degree level in relevant scientific field, PhD would be desirable Proven relevant technical experience within commercial applied reagent/chemistry related role. Technical experience in Molecular assay development and optimisation – particularly PCR, in vitro diagnostic product development, designing multiplex PCR assays and complex chemical formulation calculations. Management of external CMOs within the reagent supply chain. Product Verification & Validation experience and working to Quality Management & Regulatory framework Experience working within ISO13485 and/or 21 CFR Part 820 Strong applied chemistry laboratory-based background Experimental design, data analysis and problem solving. Experience in working with microorganisms to containment level II

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 QC Technician will be working within the Quality Control department, developing and performing laboratory tasks associated with the testing of molecular diagnostic reagents, and products, including the analysis of data. Responsibilities include: Perform testing required to approve or reject incoming raw materials, and to evaluate bulk reagents. Maintain Quality Control stocks, equipment and materials. Analyse data and review documentation associated with product release. Design, develop and validate new test methods and processes. Continual process improvement and best practise implementation. What you need to succeed Educated to degree level in relevant biological science field Previous experience as a laboratory technician Experience with PCR/molecular biology techniques Strong experience within Quality Control and have worked in a Quality Management System, and working to QC procedures, methods & processes. Working to & writing SOPs/work instructions Technical report/procedure writing Preparation of reagents & materials to recipe Statistical analysis Test Method Validation and equipment and performance verification.

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. 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.

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 R&D Manager will be responsible You will manage for managing and delivering a range of R&D projects from the development for the point-of-care diagnostic platform to adapting their current systems. You will also be responsible for managing and coaching a team of R&D scientists and engineers in a fast-paced and pro-active environment. Responsibilities include: Lead in the technical direction of the development of new assays in line with company milestones. Manage the R&D team to deliver project plans for new and existing products aligned with company objectives. Ensure that new products are developed within regulatory guidelines. Manage the smooth running of the laboratory facilities, ensure they are operating within QMS and regulatory compliance. Expand the portfolio of equipment to improve the speed and quality of service that patients receive with their diagnosis. What you need to succeed Educated to higher degree level, ideally possess a PhD in a relevant technical discipline. Experience in managing teams of 5-10 people in a busy environment, and proven experience as a strong, successful leader. Relevant R&D experience in IVD product development, molecular diagnostics or related medical devices. Experience in project management of multi-disciplinary projects. Knowledge and understanding of relevant regulatory and quality compliance procedures. Strong molecular biology or clinical microbiology experience. Strong analytical data analysis skills, including statistics and data interpretation.

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 Manage internal research and development activities in line with company objectives. Provide technical leadership in new product portfolios and technology development. Effective management of financial, human & other resources, necessary to fulfil the responsibilities of the role. Ensure all development projects are compliant to quality and regulatory standards. Drive end to end product development cycles of complex medical devices. Develop and implement R&D tools, processes, standards and metrics, including establishment of best practices. Project and maintain, at a high-profile, the company's scientific excellence to an external audience. Identify and manage external funding and scientific initiatives. Develop strategies for developing & protecting the company's intellectual property. What you need to be successful Educated to higher degree level, ideally PhD, or obtain a Masters Previous experience in a senior research & development role, having led successful teams. Proven track record focused on IVD product development on molecular products, including successful new product launches. Strong working knowledge of Quality Management System & international regulatory requirements. Ability to consistently make timely decisions even in the face of complexity, balancing systematic analysis with decisiveness. Strong strategic leader that effectively leads and guides from the front. Demonstrates quantitative and qualitative analytical and problem-solving skills.

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 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 Experience molecular biology, PCR and sample preparation.

Provide Tier 2 and above support on incident responses and resolutions. Manage frontline email and chat queries and support for customers. Research, diagnose, troubleshoot and identify solutions to resolve system issues. Review product issues and feature requests escalated to your office, ensure unresolved issues are assigned to appropriate internal teams. Manage unexpected outages and downtime. Restore the application and service operation as quickly as possible to minimize the impact to customer business operations. Provide prompt and accurate feedback to customers; ensure all issues are properly logged. Track and provide updates on support issues in alignment with the CRM software. Collaborate and coordinate with internal teams for deployment of application upgrades and enhancements Follow standard procedures for proper escalation of unresolved issues to the appropriate internal teams. Conduct trial and pretrial consultations with qualified potential customers as assigned. Handle phone calls, product demonstrations, and customer walk through as required. Collate, prioritize, and elaborate on bugs and improvements so they are more easily actioned. Work with designed guidelines, framework and instructions in order to set up a system or fix a fault.

Provide Tier 2 and above support on incident responses and resolutions. Manage frontline email and chat queries and support for customers. Research, diagnose, troubleshoot and identify solutions to resolve system issues. Review product issues and feature requests escalated to your office, ensure unresolved issues are assigned to appropriate internal teams. Manage unexpected outages and downtime. Restore the application and service operation as quickly as possible to minimize the impact to customer business operations. Provide prompt and accurate feedback to customers; ensure all issues are properly logged. Track and provide updates on support issues in alignment with the CRM software. Collaborate and coordinate with internal teams for deployment of application upgrades and enhancements Follow standard procedures for proper escalation of unresolved issues to the appropriate internal teams. Conduct trial and pretrial consultations with qualified potential customers as assigned. Handle phone calls, product demonstrations, and customer walk through as required. Collate, prioritize, and elaborate on bugs and improvements so they are more easily actioned. Work with designed guidelines, framework and instructions in order to set up a system or fix a fault. Provide prompt and accurate feedback to appropriate internal teams and customers. Follow up with clients to ensure their IT systems are fully functional after troubleshooting

Provide Tier 2 and above support on incident responses and resolutions. Manage frontline email and chat queries and support for customers. Research, diagnose, troubleshoot and identify solutions to resolve system issues. Review product issues and feature requests escalated to your office, ensure unresolved issues are assigned to appropriate internal teams. Manage unexpected outages and downtime. Restore the application and service operation as quickly as possible to minimize the impact to customer business operations. Provide prompt and accurate feedback to customers; ensure all issues are properly logged. Track and provide updates on support issues in alignment with the CRM software. Collaborate and coordinate with internal teams for deployment of application upgrades and enhancements Follow standard procedures for proper escalation of unresolved issues to the appropriate internal teams. Conduct trial and pretrial consultations with qualified potential customers as assigned. Handle phone calls, product demonstrations, and customer walk through as required. Collate, prioritize, and elaborate on bugs and improvements so they are more easily actioned. Work with designed guidelines, framework and instructions in order to set up a system or fix a fault. Provide prompt and accurate feedback to appropriate internal teams and customers. Follow up with clients to ensure their IT systems are fully functional after troubleshooting