Staff Manufacturing Engineer, Contract Manufacturing - 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:
Supply Chain Engineering

Job Sub Function:
Manufacturing Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Alajuela, Costa Rica

Job Description:

Johnson & Johnson is hiring for a Staff Manufacturing Engineer, Contract Manufacturing to join our team located in Shockwave Medical Costa Rica.

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 Staff Engineer will be responsible for technical support to the contract manufacturers and component suppliers on the implementation and validation of manufacturing lines for Shockwave products.

Including evaluation and building of prototypes, pilot, and production equipment or tooling as appropriate, troubleshooting and implementing changes to improve manufacturing quality and product performance.

The Sr.

Manufacturing and Transfer Engineer will assist in the identification and pursuit of value improvement and cost improvement projects to support operations in line with business goals and objectives.

Essential Job Functions



* Acts as the primary technical point of contact; works with our contract manufacturer and external partner to transfer and scale Shockwave manufacturing process.


* Supports development transfer activities from R&D & Operations to contract manufacturer/suppliers.


* Works with local, international suppliers and manufacturing sites to generate capacity/capability models and make vs.

buy assessments used as an input to site planning.


* Responsible for preparation and execution of validation protocols and completion of validation reports.


* Develops and maintains process risk documentation (e.g., PFMEA) to identify potential risks and implement preventive and corrective actions.


* Prepares engineering change orders and coordinates the implementation of changes including training production staff.


* Provides expertise in pro...