Sr. R&d Project Manager - Shockwave Medical

Johnson & Johnson Johnson & Johnson · Pharma · New Brighton, MN +1

This role is for a Sr. R&D Project Manager in the medical device industry, focusing on Intravascular Lithotripsy (IVL) technology. The position requires leadership in New Product Development and design change projects, ensuring projects meet timelines, budgets, and quality expectations. Responsibilities include cross-functional leadership, risk management, stakeholder communication, and overseeing the product development lifecycle from feasibility to market release, adhering to Design Control principles and relevant regulations.

What you'd actually do

  1. Responsible for R&D New Product Development, design change or Enterprise (ERC) projects by providing cross-functional program leadership to ensure projects achieve desired outcomes.
  2. 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.
  3. Responsible for ensuring the timely development and successful implementation of best practices throughout the project lifecycle.
  4. Experienced at leading complex programs while delivering milestones on time and on budget with quality per customer expectations.
  5. Skilled in project planning, risk management, project execution and communication to all levels of the organization.

Skills

Required

  • BS/BA in science, engineering or business administration or equivalent combination of education and work experience
  • 5+ years of Product Development and Design Control experience
  • at least 3 years of project management experience in the medical device industry
  • Experience in Quality System Regulations (QSR) 21 CFR 820, ISO 13485, MDR requirements, and other applicable regulations as required
  • Experience with developing, implementing, and monitoring process improvement initiatives, project management frameworks and methodologies
  • Demonstrated track record of establishing priorities and meeting deadlines
  • Strong leadership and interpersonal skills
  • navigating organizational challenges
  • work with through others and accomplish objectives
  • Capable of performing under the pressure of multiple competing deadlines
  • maintaining a cooperative and constructive working relationship with others
  • Outstanding verbal & written communication skills
  • High level of enthusiasm, motivation, and drive for results

Nice to have

  • Project Management specific training and/or certification preferred

What the JD emphasized

  • medical device industry
  • Product Development
  • Design Control
  • Quality System Regulations (QSR) 21 CFR 820
  • ISO 13485
  • MDR requirements