Sr Manufacturing Engineer

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

Job Function
Supply Chain Engineering

Job Sub Function
Manufacturing Engineering

Job Category
People Leader

All Job Posting Locations:
Alajuela, Costa Rica

Job Description
Johnson & Johnson is hiring for a
Sr Manufacturing Engineer
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
This position main responsibility is to provide engineering support to Production. Is also responsible for designing, developing, testing, and implementing processes, tooling, and fixtures for commercial product. In addition, will work closely with the development teams developing and refining manufacturing process to ensure successful transfer into the company's manufacturing operations.

Essential Job Functions

• Support and work collaboratively Production departments to design, develop, test, and implement processes, tooling, and fixtures.
• Support and work with the Quality department to address and resolve non-conformances for products already in production.
• Collect data and analyze process performance (yield and scrap) and capabilities for company products, including new products and products already in production.
• Identify requirements, advise Operations management, prepare proposals & acquisition arrangements, and implement equipment & fixturing needed for manufacturing and cost reduction projects.
• Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills-of-materials, MPI's, LHR's), 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 and transfer projects (in cooperation with development engineers and technicians).
• Assist Materials and Production departments with supplier selection and technical development.
• 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 Manufacturing Engineering or equivalent experience
• Minimum of five (5) years of experience in a medical device environment or, 3 years of experience with a Master's Degree.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs,
• FDA, ISO, MDD and other applicable regulations.
• Understanding of 6S, Lean and Lean Sigma concepts.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• Proficient in Statistics (Cpk, Hypothesis Testing, DOE's, Gage R&R) a plus.
• 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.
• There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
• Employee may be required to lift objects up to 25lbs or more. Employees will be required to work in an air conditioned office space and possibly perform some tasks in our non temperature controlled warehouse space.

Required Skills
Preferred Skills:
Accelerating, Coaching, Communication, Developing Others, Execution Focus, Facility Management, Good Manufacturing Practices (GMP), Inclusive Leadership, Leadership, Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Manufacturing Science and Technology (MSAT), Problem Management, Process Optimization, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Supply Planning