Job Description
Principal R&D
Tech Lead What You Will Do:
Lead the development of next Gen 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 Solid Works to realise complex product designs and manufacturing fixtures.Reviewing detailed 2 D 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.
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.
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.
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.
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 Solid Works and/or Creo.? Experience in using Excel/Mini Tab/Mat Lab 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.
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For more info see Skills:
R&D
Product Development Mechanical Engineer Benefits:
Work From Home