Product Design Lead
Kingston Upon Hull
Our Client is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients.
They have over 16,000 employees around the world and are now looking for a Product Design Lead to join their company which had more than $4.6billion annual sales in 2016.
Reporting to the NPD Engineering & Research Director, the Product Design Lead will have experience of the fundamentals of electrical, mechanical, software and systems engineering which enables them to take a multi-disciplinary approach to product design. This role requires both leadership of internal technical teams and also engagement with experts in the industry-leading development companies we partner with, as well as medical professionals and entrepreneurs. The Product Design Lead interprets the needs of our users and guides the direction our solutions take. The Product Design Lead will likely have a core expertise within one of Electrical, Mechanical, Software or Systems Engineering, but will have a sufficient knowledge of all to effectively act as the technical lead for complex multi-disciplinary projects.
Providing guidance and direction to project teams on the design and implementation of overall system architectures. Assisting the team in bringing together component sub-systems into a whole and ensuring that those sub-systems function together on complex electro-mechanical medical devices. Serving as an authority on system engineering approaches to designing and developing complex medical devices. Creating value for the Company’s shareholders and customers through the creation of technologies, products or processes that provide real benefit to our customers and patients. Responsible for overall project technical success, acting as technical lead for product development teams. Provide system engineering technical guidance to product development teams in the design and development of medical devices. Drives complex or novel assignments requiring the development of new or improved technology and procedures. Work is expected to result in the development of new or refined technologies, products, materials, processes, equipment, and or scientific methods. Work with cross-functional teams to define system requirements that are appropriate, realizable, and testable. Contribute to risk management and regulatory activities to ensure successful regulatory approval of the new product across our global markets. Serves as an example of engineering excellence. Applies technical rigor in problem solving and analysis. Mentors and teaches less experienced engineers. Completes documentation in a timely manner. Maintain records as required. Recommends process improvements. Partners with Manufacturing Engineering to assist in developing test methods, equipment acquisition for new product testing, validations/qualifications, statistical analysis of data for significance, and other documented requirements for quality objectives. Conduct independent technical investigations and testing, and provide technical information and guidance to project teams when making technical design tradeoffs. Lead design reviews on system level architectures and designs; conduct peer reviews of integration and system level testing. Provide system architecture review and systems testing review guidance to senior management. Identify and evaluate new technologies for incorporation into products based on the corporate portfolio strategy. Works with NPD teams to ensure verification and validation outputs meet design inputs through the creation-review-execution of test cases, and participation in new product risk analyses and design reviews.
BS or MA degree in appropriate Engineering discipline, e.g. Mechanical, Electrical, or Biomedical Engineering required. Chartered Engineer preferred. Minimum of five (5) years relevant new product development, requirements management, risk management, verification & validation, and technical leadership experience within an FDA regulated industry required. Minimum of two (2) years at senior level in medical device industry, with Line Management beneficial. Technical experience with electrical medical equipment with embedded software controls required. Technical experience with sterile disposable medical devices preferred. Experience with medical device development for international and emerging markets preferred. Medical device manufacturing experience preferred. Prior project management experience preferred.
Ability to generate engineering requirements and specifications from marketing input. Proven Line Management skills Demonstrated ability to understand clinical scenarios, conceptualizes technical solutions, explains concepts to development engineers, tests and evaluates designs and prototypes. Ability to manage outside suppliers and manufacturers as related to system and project level activities. Familiarity with the Standards, Regulations, and Guidance associated with the development and manufacture of sterile, non-sterile disposable and reusable medical devices.
Posted 9 days ago