Job Description
**Lead R&D Team for Next-Gen Medical Device Development** We are seeking an experienced R&D Tech Lead to lead the development of next-generation medical devices from clinical stage to large-scale manufacture. **Key Responsibilities:** * Lead product brainstorming sessions to resolve design challenges and generate new responses to user needs * Utilize CAD tools such as CREO and Solid Works to realize complex product designs and manufacturing fixtures * Review detailed 2D CAD drawing specifications to control design and for manufacture * Develop concepts through to manufacture-readiness using techniques such as injection moulding by considering design for manufacture principles * Oversee design transition to production and scale-up * Lead the design and execution of testing to support product release + Design testing programmes to support verification of design against product requirements + Analyze test data to support compliance with product requirements + Review prototype test data and complete statistical analyses to support design decisions * Oversee the documentation of design inputs to design outputs to ensure compliance with relevant standards + Identify and document user needs in collaboration with Clinical, Marketing and Quality colleagues + Translate user needs into product requirements + Complete literature reviews and technical reports to support documentation of design inputs, test method designs, and product features + Own risk management documents and lead cross-functional design reviews * Lead an R&D team through complex medical device design projects to deliver products to patients + Work closely with the Project Management team to identify goals, track progress, and highlight project technical risks + Oversee the work of a team of direct reports and manage inputs from cross-functional collaborators + Personally contribute novel and inventive ideas to support patent applications and enhance the company's IP portfolio **Experience Requirements:** * 7+ years of experience in product development (with at least 5 years' experience in a medical device environment) * Previous experience of design for assembly and manufacture of mid to high-volume manufacture of medical devices and/or consumer products * Experience of designing at least 3 products using CAD software such as Solid Works and/or Creo * Experience in using Excel/Mini Tab/Mat Lab to input, analyze, and draw conclusions from test data * Experience with directly creating and managing Design History File documents such as Risk Management, Design Inputs, Test Method Design and Validation, and Design Verification Plans alongside experience writing formal testing protocols and test reports * Experience working within a Quality Management System to ISO13485 standards