You are a proactive, hands-on individual looking for a role in a small team offering a wide range of challenges. You are looking for a role to gain experience in medical devices, product development and biotechnology.
Your main goal is to support the development of new and existing medical device products for Microvisk Technologies. You will have responsibility to drive the laboratory work to ensure the development pipeline is taken effectively from initial ideas and Proof of Concept through to Verification and Validation work and manufacture. You will adopt Microvisk Technologies ISO 13485:2016 Quality Management Systems principles and contribute to successful regulatory submissions and CE marking.
Under the guidance of senior members of the team you will use your skills to create competitive products from proof of concepts and initial ideas.
You will require a self-motivated, flexible attitude to manage your own workload and drive multiple projects forward.
You will have a high level of ability in data analysis, Good Laboratory Practice, record keeping, report writing and documenting of experiments understanding its importance in the development of medical devices.
You will want to get hands on in the laboratory, learning to use new equipment, new techniques and with an interest in working across different technical disciplines particularly into the area of biology.
You will also support the technical transfer of the existing PT/INR product into manufacturing using the company's existing specifications and SOPs.
You will thrive on the challenges, new technical areas and broad responsibilities that come with working in a small team but in return you will gain a range of experiences that comes with working in a startup.
Your responsibilities:
Assist in the development and optimisation of assay methodologies for point-of-care IVD assays on the MEMS based rheological platform under ISO 13485:2016 Quality Management System.
Develop and optimise assay test strips/cartridges, platform and detection techniques.
Design, carry out and analyse experiments to rapidly advance assay development and performance whilst completing robust records.
Develop and optimise assay test strips, platform and detection techniques.
Work with internal and external partners to help specify and develop device electronics & hardware, casings and software.
Work with the core team to expand the Intellectual Property and product portfolios.
Carry out light manufacturing & QC tasks to support prototype and pilot builds.
Carry out laboratory testing on clinical blood samples following GLP.
Report progress, risks, challenges and opportunities to the project team.
Work to GxP and manage and maintain the laboratory in good order to relevant HSE and ISO standards.
Identify, order and carry out COSHH assessments for all components required for development.
Create and maintain the project documentation for the full development cycle whilst meeting the required medical device standards within the company QMS.
Create and maintain QMS records and carry out the transfer of procedures to external parties.
Support the regulatory team in CE marking submissions.
Your qualifications, skills and experience:
A BSc, MSc or equivalent degree in Physics, Engineering or similar subject.
A pragmatic, self motivated hands-on worker with sound laboratory skills.
Excellent communication and report writing skills.
Good IT proficiency in Microsoft Office (Word and Excel) and knowledge of statistical packages such as Matlab or Minitab (desirable).
Basic programming skills and/or a desire to self-start in learning to setup automation of equipment and experiments eg. Python, LabView, Excel VBA, C/C++/C# etc.
Located at Worminghall, near Oxford but able to travel within the UK and abroad to support the R&D projects and transfer to manufacturers.
Candidates must have the right to work in the UK.
Company Overview:
Microvisk is a small, motivated company looking to expand its IVD assay portfolio beyond its initial PT/INR product CoagMax. The company has 6 granted patent families for its unique MEMS based rheological assay platform and requires a talented individual to make key contributions to bring new products to market. Founded in 2004, the company is under new management and is now based in Oxford. The company is in new premises in Worminghall, near Oxford. The company operates under an ISO 13485:2016 Quality Management System.
Job Types: Full-time, Permanent
Pay: 25,000.00-30,000.00 per year
Benefits:
Casual dress
Company pension
Free parking
On-site parking
Education:
Bachelor's (required)
Language:
English (required)
Work authorisation:
United Kingdom (required)
Work Location: In person
Beware of fraud agents! do not pay money to get a job
MNCJobs.co.uk will not be responsible for any payment made to a third-party. All Terms of Use are applicable.