Job Description

Senior R&D Scientist, Medical Devices

Location: York

Type: Permanent

Salary: CIRCA \xc2\xa334,000

Additional: Includes but not limited to: 25 holidays per year rising to 30 with service, upto 6% matched pension, healthcare and benefits platform

The role is that of R&D Senior Scientist to support the growing pipeline of diagnostic projects. This role is within the R&D team and involves assisting with working on development projects from the point of feasibility though scale up and transfer into manufacturing. As a senior scientist you will also be expected to oversee and plan the work of development scientists when appropriate.

The role requires familiarity with, and keeping up to date with, established and emerging technologies in the medical devices/ diagnostic industry in particular relating to point of care testing to ensure our service provision is maintained at the highest standard possible.

The role:

• Independently create project experimental work plans to deliver technical work on time in conjunction with the project manager / Senior R&D Management
• Bring a significant area of expertise to the team and disseminate that knowledge to the team
• Understand the assay design and development process and identify improvements in the technical methods used in the development process
• Review and approve R&D scientist reports and data generation for presentation to external customers
• Understand technical issues and identify solutions proactively
• Assisting in the development of assays for third parties and internal product development
• Working with colleagues across R&D, Manufacturing, quality and regulatory to ensure projects achieve design review milestones on time and on budget
• Ensure work is completed to required health and safety standards including preparation of COSHH and Risk Assessments.
• Prepare and present data as and when required, analysis of results and generation of data using excel / other statistical packages. Contribute to internal and external team meetings
• Prepare written SOP\'s for laboratory methods, procedures and instrumentation
• Assist in the generation of marketing materials, specifically the technical content
• Understand the requirements for the project design history files (DHF) and actively work with the Project Manager to ensure the DHF technical requirements are appropriate for audit
• Review of other scientist / senior scientists experimental writes ups to achieve consistent quality and meet all QMS requirements
• Ensure training record is up to date & help train new starters where appropriate
• Assume ownership for maintenance of equipment / processes as the department requires
• Ensuring that all relevant procedures are followed and compliance is at least maintained in line with the current versions of ISO:9001 and ISO13485
• Participate in audits when required
• Participate in supplier meetings / discussions

The Person:

• Will hold a Degree in a relevant subject area
• Understanding of immunoassays
• Will need to have worked in an IVDR/ diagnostic or similar (MDR/ISO 13485) setting to be considered for this role.
• Technical / PM experience and /or experience of report writing

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us .

Russell Taylor Group