Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
The Sr. R&D Project Manager is responsible for new product development and design changes projects by providing cross-functional program leadership to ensure projects achieve desired outcomes. 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. Responsible for ensuring the timely development and successful implementation of best practices throughout the project lifecycle.
Essential Job Functions
- Experienced at leading complex programs delivering milestones on time and on budget with quality per customer expectations.
- Skilled in project planning, risk management, project execution and communication to all levels of the organization.
- Effectively manage multiple small projects or one large project; drives for accountability within self and others.
- Oversee of all phases of the product development process from Feasibility to Market Release, with excellent understanding of Design Control principles.
- Communicate with a variety of stakeholders at all levels effectively, including executives with differing priorities.
- Publish routine dashboards and reports that effectively communicate progress, risk and achievements of the overall portfolio.
- Take ownership of hands-on management and tracking of overall team progress and provide detailed management status reports and updates.
- BS/BA in science, engineering or business administration or equivalent combination of education and work experience.
- Experience in Quality System Regulations (QSR) 21 CFR 820, ISO 13485, and MDR.
- 8+ years’ Product Development and Design Control in the medical device industry.
- Project Management specific training and/or certification preferred.
- Experience with developing, implementing, and monitoring process improvement initiatives, project management frameworks and methodologies.
- Strong leadership and interpersonal skills, adept at navigating organizational challenges and possess ability to work with through others and accomplish objectives.
- High level of enthusiasm, motivation, and drive for results.
- Demonstrated track record of establishing priorities and meeting deadlines.