【Shockwave】Senior Project Manager, R&D

Job Description

Position Overview

The Sr. R&D Project Manager is 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. 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.

Responsibilities

• Experienced at leading complex programs while 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.
  • Collaborate closely with Japan’s Commercial, Regulatory, Quality, and Supply Chain teams to align business needs, compliance requirements, and market dynamics with global strategies.
  • Lead the process to release products to finished goods, distribute commercial and investigational finished goods, and trace product to the end user.
  • Oversee regulatory submission document preparation, localization readiness, and other downstream project activities to support new product launches in Japan.
  • Partner with the commercial team to gather customer feedback and translate insights into product improvements and development strategies.
  • Support commercial operations initiatives and projects to enhance business efficiency in Japan.
• Oversee of all phases of the product development process from Feasibility to Market Release, and business growth initiatives for the Japan market 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.
• Develop and deliver formal communications, including presentation skills when needed.
• Take ownership of hands-on management and tracking of overall team progress and provide detailed management status reports and updates.
• Other duties as assigned.

Qualifications

• 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 and 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.
• Project Management specific training and/or certification preferred.
• 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, adept at navigating organizational challenges and possess ability to work with through others and accomplish objectives.
• Capable of performing under the pressure of multiple competing deadlines while maintaining a cooperative and constructive working relationship with others.
• Outstanding verbal & written communication skills.
• High level of enthusiasm, motivation, and drive for results.

・If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.
・Once you move to 1st interview stage, please make sure to inform to your current manager.
・For Employee Referral Program (ERP), please read and understand the details of “Employee Referral Program” in Ask GS and make a compliant referral.

About the Company

Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years.

The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world.