· Responsible for the creation of the project work breakdown structures, risk management, integrated business plans and product requirements. Leads the cross functional development of product architecture 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 direction of the project. Able to create and influence novel thinking of the team.
· 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.
· 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.
· Communicating project risks and mitigations to the Leadership Teams.
· Collaborates with cross functional team to ensure timely delivery, review and approvals via multiple regional registrations as well as other conflicting/dependent programs.
· Responsible for the execution, quality, and results of the projects and the success of the resulting products for the business or in the market.
· Interacts with functional managers and business leaders to communicate regarding critical project risks, questions or challenges.
· Challenges core team members, functional leaders and business leaders regarding functional and cross functional strategies and approaches in order to improve program development outcomes.
· Analyzes development situations and data with in-depth evaluation of multiple factors.
· Influences solutions to business or technical problems.
· BS degree in Mechanical Engineering, Chemical Engineering, Materials Science & Engineering, Biomedical Engineering or a closely related engineering degree is required. An advanced degree in an engineering discipline or MBA is preferred.
· At least 10 years relevant experience in product development and design is needed.
· 3+ years of experience leading cross-functional, global teams through complex projects or programs. Program management experience preferred.
· Complete understanding of a wide application of project management principles, theories & concepts.
· Experience in new product development planning multiple work-streams, identifying risk and implementing action plans to optimize timelines and reduce execution risk.
· Experience establishing customer requirements from defined needs specifications and translating to product requirements.
· Excellent interpersonal, communication, presentation and influencing skills.
· PMP certification or equivalent.
· Knowledge of global regulatory (FDA, Anvisa, NMPA, MDR) and quality requirements (ISO, GB, JISC etc.)
· A six-sigma design and development background.
· Has successfully launched medical device products from concept through launch.
· Experience developing Class II and III medical devices.
· Experience developing drug-device combination products.
· Experience utilizing combination of analytical, statistical, computational, and empirical methods to gain deep understanding of design and minimize overall development timelines.