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.comJob Function: Supply Chain EngineeringJob Sub Function: Manufacturing EngineeringJob Category: People LeaderAll Job Posting Locations: Alajuela, Costa RicaJob Description:Johnson & Johnson is hiring for a Manager Manufacturing Engineering 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 OverviewThis role is responsible for designing, developing, testing, validating, and implementing processes, tooling, and fixtures for products that are developed by the Research and Development (R&D) group. This position will work closely with development teams and serve as a core member of the team through successful transfer into the company’s manufacturing operations.Essential Job Functions
Work collaboratively with R&D, Quality and Production departments to design, develop, test, validate and implement processes, tooling, and fixtures.
Collect data and analyze process performance and capabilities for company products, including new products and products already in production.
Perform tolerance analyses for components, manufacturing materials, packaging, and supplies used for in-house processing.
Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes.
Participate in development and maintenance of product design FMEAs.
Identify requirements, advise Operations management, prepare proposals and implement equipment & fixturing needed for development and manufacturing efforts.
Develop and maintain documentation for design control, product configurations (e.g., bills-of-materials), and other Quality System requirements.
Lead and/or actively participate in product/process engineering problem resolution.
Lead and/or actively participate in process/product improvement projects, Product transfers, line setup, Validation activities (IQ, OQ and PQ) in cooperation with R&D engineers, Quality and technicians
Lead the Manufacturing Engineers and Technician and provide them feedback and guidance.
Assist Materials, QA and R&D departments with supplier selection and technical development
Conduct complex engineering studies and investigations and prepare reports for company leadership
Provide engineering guidance to other departments, help to train new engineers and keep abreast of industry trends and issues.
Perform productivity and costing analyses (e.g., calculate direct labor & materials costs for new products, identify and implement cost reduction plans for existing products).
Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.
Requirements
Bachelor’s degree in Engineering discipline (Mechanical, Biomedical, etc.) or equivalent experience
Minimum of seven (7) years of experience in medical device manufacturing.
Advanced English
Experience with process validations (IQ-OQ-PQ), Lean Sigma, 6S.
Strong in Statistics (process capability, CPK, DOE’s, Normality, Hypothesis Testing).
Demonstrated proficiency in written and verbal communication, including creating and delivering presentations
Advanced skills in critical software applications, such as Microsoft Office.
Basic Solidworks Knowledge
Expertise in data and problem analysis, creative problem solving and design thinking.
Tooling and Equipment design a plus.
Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements)
Ability to work in a fast-paced environment while managing multiple priorities
Operate as a team and/or independently while demonstrating flexibility to changing requirements.
