Veranex's mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.
Requirements
- Strong understanding of design and document controls, design verification and validation, hazard analysis techniques, regulatory approval methods
- Understanding of mechanical engineering development processes
- Understanding of electronics and software development
- Familiarity in the design of complex medical capital equipment and disposable devices
- Sound program management skills
Responsibilities
- Develops and maintains schedule, ensures schedule has been reviewed and submitted to management.
- Advocates and maintains appropriate interdisciplinary resource loadings needed to maintain product development project deliverables, including budget and schedule.
- Maintains program oversight over all disciplines.
- Ensures individual discipline leaders are aware of client overall objectives and the responsibilities to their responsibilities to the specific programs.
- Develops appropriate presentations of activities during each phase of the program.
- Conducts post-mortem with team members and senior management on each phase during the project.
- Monitors internal resources to ensure all products are developed within cost targets and delivered on schedule.
Other
- Responsible for managing and executing product development program direction in accordance with the client and development team goals.
- Manages a variety of programs and leads various disciplines in executing the required deliverables.
- Submits weekly product development project status to management and/or client.
- Ensures team members are accurately entering hours into the accounting system on a weekly basis.
- Escalates issues as appropriate to higher level management.
