Lead cross-functional and/or cross-company teams to develop and commercialize new diabetes-related medical devices and software/digital products. He/she is expected to be directly involved in problem solving and decision making by the various project teams, and must assure that the decisions are consistent with the overall commercial and Divisional objectives of the program.
- Formulates, harmonizes and consolidates project scopes, plans, strategies, and budgets for one or more projects, working closely with functional Project Managers and other Subject Matter Experts from R&D, Commercial, Clinical, Regulatory, Quality, Manufacturing, and other functions.
- Confirms the ongoing strategic rationale for projects, and for the ongoing planning, scheduling, monitoring and reporting or projects.
- Ensures Division-wide thinking and problem-solving are incorporated into project execution.
- Drives for resolution in cross-functional problem solving, communication, and integration.
- Serves as the liaison between the team and management.
- Raises issues to the appropriate level of management.
- Prepares and presents information on an as-needed basis to assure the continuity of projects.
- Executes programs to completion and assures successful market entry, or makes a timely recommendation to Management to terminate a program if required by technical, commercial or other developments that may result in project failure if not resolved through creative problem solving.
- The Project Leader has responsibility for leading a multi-functional product development team.
- The incumbent has the responsibility to work with the functional program managers, Subject Matter Experts, project teams and management to ensure strategic alignment and execution toward cost and timeline commitments.
- The Project Leader is responsible for ensuring that project valuation data is current, and that key project value assumptions are intact.
- This position is highly visible and accountable, responsible for reporting to Senior Management the activities, issues, and risks in the development and commercialization of the new product.
- Employees reporting through matrix team: 5 to 10.
- The Project Leader is primarily a matrix manager for assigned programs’ project team with no direct reports.
Typically, the incumbent would have a Bachelors or Master's degree in a business or a technical discipline. Technical background in engineering, computer science, chemistry or physics preferred. MBA desirable.
1. Minimum 7 years’ experience as a Project Director/Project Manager in a medical device or software company, preferably including experience with consumer-focused products
2. Cross-functional experience in the areas of R&D, Commercial, Clinical, Regulatory, Quality, and Manufacturing are desired
3. Knowledge of regulations and standards related to medical devices is a plus (eg FDA, ISO, QSR design controls)
4. Demonstrated track record of successfully managing medical device / software projects from concept to market
5. Proven ability to lead software development projects and ensure objectives, goals, and commitments are met
6. Solid understanding of and demonstrated experience in using Agile methodologies, processes and tools such as Jira or equivalent
7. Understanding of the software development lifecycle process
8. Excellent interpersonal skills and demonstrated ability to work with a wide variety of people at all levels of the organization within a variety of departments
9. Strong leadership, and the ability to collect information from multiple sources, and synthesize, integrate, and resolve conflicting requirements and cross-functional issues.
10. Excellent verbal and written communication skills
11. Excellent negotiation and influence skills