Sr. Principal R&D Project Manager - Shockwave Medical

6947-SHOCKWAVE MEDICAL INC. Legal Entity; Santa Clara (CA); On-site; USD 134,000 - 231,000; Full time

Benefits offered by this job

Pension Plan

401(k) Savings Plan

Paid Time Off

Job summary

Johnson & Johnson in Santa Clara, CA seeks a Sr. Principal R&D Project Manager to lead product development and cross-functional alignment for Shockwave Medical devices. You will drive planning, risk management, and communications across teams from feasibility to market release.

The role requires extensive medical device project management experience, strong leadership, and deep knowledge of regulatory pathways (QSR, ISO 13485, MDR). A collaborative, results‑driven style is essential.

Qualifications

• BS/BA in science, engineering or business administration or equivalent.
• 12+ years of Medical Device experience including at least 7 years in project management.
• Experience with QSR 21 CFR 820, ISO 13485, MDR requirements and related regulations.

Responsibilities

• Coordinate cross-functional activities across the product development lifecycle.
• Lead project planning, risk management, and status reporting to leadership.
• Establish strategy and ensure organizational alignment for multiple parallel projects.
• Oversee all phases from feasibility to market release with Design Control principles.
• Mentor other Project Managers in the group.

Skills

Project management

Regulatory expertise

Leadership

Communication

Cross-functional coordination

Risk management

Process improvement

Ambiguity navigation

Stakeholder influence

Mentoring

Education

BS/BA in science, engineering or business administration

Tools

PM methodologies (PMM/PMO)

Quality management systems

Job description

Job Function: Project/Program Management Group

Job Sub Function: R&D Project Management

Job Category: Professional

All Job Posting Locations: Santa Clara, California, United States of America

Job Description

Johnson & Johnson is hiring for a Sr. Principal R&D Project Manager– Shockwave Medical to join our team located in Santa Clara, CA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio 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.

Position Overview

The Sr. Principal R&D Project Manager is responsible for product development, resource, and project management activities associated with executing the company’s goals for product commercialization. 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. The role supports R&D New Product Development and/or On Market.

Essential Job Functions

• Manage and coordinate all cross-functional activities within the project and consistent with company’s new product development lifecycle and Design Control requirements.
• Highly skilled in project planning, risk management, project execution and communication to all levels of the organization.
• Establish project strategy, vision, and maintain organizational alignment to it, both inside and outside the team.
• Effectively drive multiple parallel projects with unique cross-functional team members.
• Oversee all phases of the product development process from Feasibility to Market Release, with excellent understanding of Design Control principles.
• Publish routine dashboards and reports that effectively communicate progress, risk and achievements of the overall portfolio.
• Develop and deliver formal communications, including effective presentation skills.
• Hands‑on management and tracking of overall team progress and ability to provide detailed management status reports and updates.
• Mentoring other Project Managers in the group as needed.
• Ability to lead complex new product development projects from concept to launch.
• Other duties as assigned.

Requirements

• BS/BA in science, engineering or business administration or equivalent combination of education and work experience.
• 12+ years of Medical Device experience including a minimum of 7 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 is highly preferred.
• Experience with developing, implementing, and monitoring process improvement initiatives, project management frameworks and methodologies.
• Highly capable performing under the pressure of multiple competing deadlines while maintaining a cooperative and constructive working relationship with others.
• Demonstrated ability to influence at all functions and levels of the organization.
• Excellent leadership and interpersonal skills, adept at navigating organizational challenges and possess ability to work through others and accomplish objectives.
• Outstanding verbal & written communication skills.
• High level of enthusiasm, motivation, and drive for results.
• Proven ability to navigate ambiguity.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills: Preferred Skills: Agility Jumps, Business Alignment, Coaching, Collaboration, Continuous Improvement, Operational Excellence, Performance Measurement, Process Control, Process Improvements, Project Management Methodology (PMM), Project Management Office (PMO), Project Reporting, Project Schedule, Quality Control (QC), Research and Development, Tactical Planning, Technical Credibility

Pay and Benefits

The anticipated base pay range for this position is : $134,000.00 - $231,150.00

Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long‑term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits