Sr. Site Transfer Manufacturing Engineer - 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 jnj.com

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Job Function:

Supply Chain Engineering

Job Sub Function:

Manufacturing 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. Site Transfer Manufacturing Engineer - Shockwave Medical 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. Site Transfer Manufacturing Engineer leads and executes product and process transfers between manufacturing sites (domestic and international), ensuring successful, compliant, and timely ramp of on-market products. This role is the primary technical lead for multi-site transfers, coordinating cross‑functional teams (R&D, QE, Regulatory, Supply Chain, Production, and External Partners) to deliver validated, robust manufacturing processes at the receiving site.

 

Essential Job Functions

• Lead end-to-end site-to-site transfer projects, from transfer planning and risk assessment through validation, production ramp, and post-transfer monitoring.

• Create and manage detailed Transfer Plans and timelines, including resource needs, milestones, deliverables, and go/no‑go criteria.

• Develop and maintain process pFMEAs, risk mitigation plans, and transfer-specific mitigation actions.

• Define user and functional requirements for equipment and systems at the receiving site; lead equipment qualification and installation activities (IQ/OQ/PQ).

• Oversee process validation and qualification activities at both sending and receiving sites; ensure data integrity and compliance with protocols.

• Coordinate cross‑site documentation transfer: BOMs, work instructions, MPIs, LHRs, configuration control, and design control elements as applicable.

• Lead or participate in system integrations required for transfer (MES/ERP/PLM), including data migration, validation, and end‑user training.

• Plan and execute capability studies (Cpk), DOE, tolerance analyses, and other statistical evaluations to demonstrate process equivalency and capability at the receiving site.

• Collaborate with Supply Chain and Procurement to ensure material, component, and supplier readiness; qualify alternate suppliers when needed.

• Provide technical leadership during production ramp: troubleshooting, root-cause analysis (DMAIC), corrective actions, and optimization to achieve targeted yields and throughput.

• Define and track relevant transfer KPIs (e.g., schedule adherence, yield, Cpk, cost variance) and report status to stakeholders and leadership.

• Mentor and coach engineers and technicians on site transfer best practices and regulatory requirements.

• Support regulatory submissions, audits, and inspections related to transferred products and processes.

• Travel between sites as required to lead transfers and supp