Sr Mgr R&D Electrical Eng, Systems - Shockwave

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:

People Leader

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr Manager of R&D Electrical Engineering Systems – Shockwave to join our team located in Santa Clara, CA.

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. Manager of R&D Electrical Engineering Systems provides leadership in the development and sustaining of innovative products to treat vascular diseases, technical support, and effectively manages and develops direct reports. Responsible for product and process development, resources, and project management activities associated with executing the company's goals and objectives, consistent with Shockwave Medical’s strategic plan.

Essential Job Functions

• Manage, lead, and mentor engineer(s); may include multiple level reporting structure (mechanical and electrical engineering).
• Lead cross-functional project activities of product and fixture testing and development.
• Mentor and support a variety of development and engineering activities, which mainly focus on capital equipment design and development (primarily pulse generators).
• Provide guidance to other managers cross-functionally and within R&D.
• Design and develop product(s) and fixtures in full compliance with the company's Design Control requirements and consistent with FDA, ISO, MDD, MDR and other applicable regulations/requirements.
• Coordinate technical personnel and their activities involved in testing and developing new and improved products, fixtures, and manufacturing processes.
• Ensure that development activities are properly documented through lab notebook, PLM requirements, design history file, and other records.
• Coordinate cross-functional alignment and support for program success.
• Manage outside vendors and contractors providing products or services.
• Create, maintain, and communicate project timelines for development projects.
• Provide regular updates of key milestones and issues to the project team as well as management.
• Identify issues and recommend solutions for products in development.
• Proactively identify and resolve challenges which could significantly delay project timelines.
• Work under high level of autonomy.
• Provide leadership, goal setting, communication and facilitation skills as needed to guide and motivate project personnel.
• Contribute ideas to new designs, as defined by product specification requirements.
• Approve test methods, acceptance criteria, and test equipment for all stages of product development.
• Coordinate and participate in events, which provide clinical feedback such as animal studies, physician interface meetings, and Human Clinical Studies.
• Ensure that products satisfy acceptable quality standards and customer needs with consensus from cross-functional groups.
• Review and approve documents as specified in Document Control SOP.
• Compile the Design History File and conduct design reviews in compliance with Design control procedures.
• Ensure that products have capable manufacturing processes and that process verifications and validations are completed.
• Interact with cross-functional groups to ensure that products are compatible with other products in the intended operating system and have met all requirements per design control process.
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