Sr. R&D Engineering Project Specialist - Shockwave Medical

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

Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr. R&D Engineering Project Specialist – 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. R&D Engineering Project Specialist will work with other R&D project team members to manage early-stage R&D project activities. Under minimal supervision, the Sr. R&D Engineering Project Specialist will track design documentation status, design changes, procurement and management of materials, collection and organization of test data, configuration management of prototype and pilot units, and other logistics as needed for early-stage R&D projects.   

Essential Job Functions

• Manage and track project document releases and changes within the Quality Management System.

• Manage collection and disposition of project generated data.

• Manage procurement, receipt and handling of R&D project materials.

• Release change orders associated with project documents, equipment, and materials.

• Collaborate with Shockwave supply chain management, operations, and facilities for warehouse setup related to R&D materials.

• Ensure compliance with Shockwave environmental safety and various regulatory requirements specific to R&D materials.

• Manage assembly of prototypes, pilot runs, and controlled units for clinical study use.

• Track configuration management of prototype and pilot builds.

• Prepare systems and samples for testing.

• Align timelines and shipment plans with project teams.

• Other duties as assigned.

 

Requirements

• Bachelor’s degree in biomedical, electrical, mechanical, systems, or relevant engineering discipline and a minimum of 5 years’ engineering experience in medical devices.

• Experience with EN60601-1 and collateral standards as they apply to medical electrical equipment

• Experience using issue tracking tools such as JIRA

• Experience using source control repository tools such as GIT or SVN

• Experience using requirements tracking tools such as JAMA

• Strong organizational and time management skills

• Excellent communication and interpersonal skills