Tandem Diabetes Care is looking to develop and deliver new medical device products to market by managing complex software projects and/or system-level programs through their product development process.
Requirements
- 4 years’ directly related experience in managing projects in FDA-regulated and ISO 14971 certified industry.
- 4 years’ experience in the medical device industry and compliance with internal Quality Systems.
- 3 years’ experience in managing projects from inception to post-market sustaining using a phase-gate methodology.
- Experience in the implementation of regulatory requirements for medical device development such as FDA’s Design Controls, ISO’s Risk Management and Medical Device standards, ISO Software Development standards (e.g., IEC 62304).
- Proficient in the use of Project Management Tools for planning, work breakdown, scheduling, task estimation, and collaboration.
- Advanced Microsoft Office skills: Excel: Forms, Formulas, Functions, Pivot Tables, & Graphs; PowerPoint: Graphics & Animation; MS-Project: Resource loading, tracking
- Knowledge and experience of web applications or Cloud software a plus.
Responsibilities
- Provides project management expertise and leadership to a multi-functional core team from Concept through Commercialization following Tandem’s standard process for product development and/or Design change; ensures implementation and compliance to Design Control procedures and improvements of systems, procedures, and documentation.
- Plans and directs all aspects of software/systems projects/programs.
- Establishes project plans and objectives, develops project cost analysis, establishes and manages the project schedule and budget, manages resources, tracks progress, and provides updates to management and external partners.
- Works closely with the Program Office, Project Managers, and functional heads to resolve resource allocation issues, conflicts, and priorities and to ensure projects are staffed appropriately, completed on time, and within budget constraints.
- Ensures efficient transfer of product from R&D to manufacturing and external marketing.
- Leads/participates in process improvement initiatives related to product development, resource management and allocation, design controls, and other areas that impact cycle time, efficiencies, and compliance in medical device product development.
- Communicates and presents regular and timely project status updates to various levels of the organization including the executive leadership team and external partners.
Other
- Bachelor’s degree in engineering or a related field; or a combination of education and applicable experience.
- Ability to work in matrixed environment, establishing a sphere of influence with both the functional and vertical organizations.
- Ability to drive cultural change through implementation of best practices in project teams.
- Ability to communicate and influence up to manage project scope and resources.
- Ability to lead cross-functional project teams with focus, motivation, and creativity to consistently meet project timelines.
