Successful bio-science medical device startup based in Wiltshire are looking for a Director of Systems Engineering.
We are partnering with an exciting diagnostic start-up based in Wiltshire. They improve sexual health and wellness through new delivery methods that prioritise clinical integrity and consumer convenience. Their solutions break down screening barriers through discreet patient-tailored individualised digital approaches that complement traditional brick-and-mortar care.
They have the world's fastest FDA-cleared molecular platform for CT/NG testing.
In addition to the "test and treat", point-of-care (POC), molecular diagnostic platform, they provide a first of its kind, comprehensive digital program that includes evidence-based testing, counselling, treatment, and follow up in order to increase screening and reduce infections.
They are now expanding the platform including COVID-19 testing as well as a broad menu for sexual and women's health.
Due to the rapid growth of the company, they are now looking for a Director of Systems Engineering to help guide them into a bright future.
We are looking for a Director of Systems Engineering to lead engineering technical insight within the business, maintain an overview of all technical aspects of the io POC platform and cartridges, and develop engineering solutions for the existing product range or for new products. Additionally, we are looking for the Director of Systems Engineering to drive and oversee investigation and development activities from an engineering perspective. This person will plan and evaluate network technologies to enable, enhance, and support connectivity and integration. This role will provide device integration engineering services to research areas including selection, acquisition and service, technical investigations, and clinical/technical problem-solving. They will also lead quality improvement activities and suggests innovative solutions to technical problems, prepare documents for and support regulatory submissions and mentor other engineers both in technical and professional development.
Bachelor's degree in Clinical Engineering, Bio-medical Engineering, Systems Engineering or related engineering field.
At least 10 years' experience in healthcare or molecular engineering with 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, focused on PCR and sample preparation.
Strong skills in management of engineering projects and/or personnel
Ability to diagnose and solve technical and/or system problems of a high degree of complexity
Knowledge of electronic, mechanical and/or computer re-engineering design and applications principles
Knowledge of clinical systems architecture used for medical device interoperability
Strong level of computer literacy and the use of word processing, spreadsheets, databases, graphics, statistics, engineering tools and programming.Job Offer
Excellent salary and benefits