Principal R&D Tech Lead

Principal R&D Tech Lead What You Will Do: Lead the development of nextGen device from clinical stage through to large scale manufacture, including: Leading product brainstorming sessions to resolve design challenges and generate new responses to user needs. Utilising CAD tools such as CREO and SolidWorks to realise complex product designs and manufacturing fixtures. Reviewing detailed 2D CAD drawing specifications to control design and for manufacture. Developing concepts through to manufacture-readiness using techniques such as injection moulding by considering design for manufacture principles. Overseeing design transition to production and scale-up. Lead the design and execution of testing to support product release by: Designing testing programmes to support verification of design against product requirements. Analysing test data to support compliance with product requirements. Reviewing prototype test data and completing statistical analyses to support design decisions. Oversee the documentation of design inputs to design outputs to ensure compliance with relevant standards through: Identifying and documenting user needs in collaboration with Clinical, Marketing and Quality colleagues. Translating user needs into product requirements. Completing literature reviews and technical reports to support documentation of design inputs, test method designs, and product features. Owning risk management documents and leading cross-functional design reviews. Lead an R&D team through complex medical device design projects to deliver products to patients by: Working closely with the Project Management team to identify goals, track progress, and highlight project technical risks. Overseeing the work of a team of direct reports and managing inputs from cross-functional collaborators. Personally contributing novel and inventive ideas to support patent applications and enhance the company's IP portfolio.? your list of tasks independently and ensure actions are completed on time. Experience Requirements - The Ideal Candidate Must Have: 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 SolidWorks and/or Creo.? Experience in using Excel/MiniTab/MatLab to input, analyse, 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. At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details. Privacy Policy: By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions. For more info see Skills: R&D Product Development Mechanical Engineer Benefits: Work From Home