Principal R

Our client a leading Medical device start up is hiring a Principal R&D Engineer

Responsibilities include but are not limited to the following:

• Lead the development of the Company's novel  device from clinical stage through to large scale manufacture
• Lead the product brainstorming sessions to resolve design challenges and generate new responses to user needs.
• Utilise CAD tools such as CREO and SolidWorks 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 completing statistical analyses to support design decisions.
• Oversee the documentation of design inputs to design outputs to ensure compliance with relevant standards
• Identify and documenting 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.
• Owning risk management documents and leading cross-functional design reviews.
• Lead an R&D team through complex medical device design projects to deliver products
• 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 managing inputs from cross-functional collaborators.
• Personally contributing novel and inventive ideas to support patent applications and enhance the company’s IP portfolio. 

• 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 ISO 13485 standards.
• Knowledge of validating plastics forming techniques such as dip moulding, blow moulding and thermoforming would be an advantage as would experience interacting with medical device regulatory requirements and applicable standards, in particular FDA guidance and IEC 60601.

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

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