Sr. R&D Program Manager
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Skills
About the role
About the role
The Sr. R&D Program Manager is responsible for product development, resource and project management activities associated with executing the company's goals for product commercialization and post-commercialization activities. You will also have ownership for company’s Product Development Process (PDP). You will be responsible for gaining cross functional alignment on strategic vision and goals of projects, meeting project goals and ensuring that appropriate resources are identified and allocated.
Qualifications
Education and Training:
BS in Engineering and a minimum of 8 years’ experience in medical device development, including experience in leadership roles in all phases of product development
Skills and Experience:
- PMP certification is highly desirable
- Knowledge of QSR, MDR and applicable Quality System Standards.
- Experience with medical device development of both disposable and capital equipment
- Experience taking a product from concept through clinical or commercial release.
- Ability to work in a fast-paced environment while managing multiple priorities
- Excellent communication skills both verbal and written
Key Responsibilities
- Design and develop product(s) in full compliance with the company's Design Control requirements and consistent with FDA, ISO and MDD requirements.
- Develop and improve product lines and strategize new product plans in conjunction with Galvanize Management.
- Partner with operations on initiatives related to commercial products.
- Manage technical personnel and their activities involved in the development of new and improved products and/or manufacturing processes.
- Ensure that development activities are properly documented through lab notebook, history file, and other records.
- Manage and coordinate all cross-functional activities within the project and consistent with company's PDP.
- Coordinate cross-functional alignment and support for program success.
- Manage outside vendors and contractors that provide products or services to Galvanize.
- Create and maintain project timeline and budgets for internal and outside develo