Experience
Applies extensive technical expertise in sensing systems, electromechanical systems and software products.
Develops technical and business process solutions to complex problems which require the regular use of ingenuity and creativity. In partnership with the platform and core team members, leads the development and commercialization, go to market and launch strategy for the project(s).
Responsible for the creation of the project work breakdown structures, risk management and integrated business plans. Leads the cross functional development of product deliverables for each functional area, synthesizes functional plans and identifies critical interdependencies to drive successful execution of the project.
Technical and business skills and judgment to significantly influence the technical and business direction of the project. Able to create and influence novel thinking of the team.
Ability to lead and drive the identification, validation, and mitigation planning of all project risks, including technical, schedule, business, resource, based on thorough understanding of the technical and business content of the integrated project plan and the work breakdown.
Ability to communicate complex technical and business issues completely, concisely, and effectively to enable high-quality decision making and drive cross-functional alignment.
Has a thorough understanding of all functional work streams in a phase gate process and a vision of an integrated project plan.
Ability to integrate technical, business, and customer information to generate novel and differentiated solutions and concepts.
Ability to architect every detail of a product based on thorough understanding of detailed customer needs and objectives.
Ability to engage all appropriate functions to define and make technical and business tradeoffs within the concept and product.
Finds and creates new avenues of excellence. Self-starting and will take action without prompting or direction from others to solve problems.
Constantly looks for improvements in work processes and results by anticipating and dealing with problems and encouraging others to suggest innovations and improvements
Represents the organization as the prime contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.
Requirements:
BS degree in Electrical Engineering, Computer Engineering, Mechanical Engineering, Biomedical Engineering or a closely related engineering degree is required. An advanced degree in an engineering discipline or MBA is preferred.
At least 12 years relevant experience in product development and design with at least 8 years product development and design experience in medical devices/products with the last four years in a program leadership role on a complex medical device product.
Previous experience with leading the development of complex software enabled electro-mechanical products.
Successful track record of commercializing new products
Knowledge of FDA QSR, ISO 13485 and 14971. Experience with executing delivery of software per SDLC processes preferred
Experience in new product development planning multiple work-streams, identifying risks and implementing action plans to optimize time lines and reduce execution risks
Experience establishing customer requirements from defined needs specifications and translating to product requirements
Experience utilizing combination of analytical, statistical, computational, and empirical methods to gain deep understanding of design and minimize overall development timelines preferred
Demonstrated ability to act as a change protagonist
Experience managing ambiguity preferred
Demonstrated learning agility of new subject matter
Excellent interpersonal, communication, presentation and influencing skills