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 **Manufacturing Engineer I** to join our team located in **Shockwave Medical Costa Rica.** Position Overview The Manufacturing Engineer I is responsible for providing manufacturing engineering support to Product Development teams. The Manufacturing Engineer is also responsible for designing, developing, testing, and implementing processes, manufacturing work instructions, tooling, and fixtures for products in the Product Development process. **Core Principles & Values** + Patient & Customer Focus: Prioritize safety, quality, and efficacy in every decision. + Innovation & Continuous Improvement: Drive technological advancements and process excellence to improve healthcare outcomes. + High Standards & Compliance: Maintain rigorous adherence to QSRs, FDA, ISO, and internal standards. + Integrity & Respect: Foster a culture of transparency, ethical behavior, and mutual respect. + Teamwork: Foster a culture of teamwork and collaboration. Essential Job Functions • Work collaboratively with Process Development and Production departments to design, develop, test, and implement processes, tooling, and fixtures. • Support Process Validation activities in accordance with the Design Control process. • Perform process characterization of new manufacturing processes, evaluate Design of Experiments data, and make improvements to optimize processes used to manufacture new products. • Write robust manufacturing process instructions to be used in a production environment. • Collect data and analyze process performance and capabilities for new products. • 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. • 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 and improvement projects. • Assist different departments with supplier selection and component development. • Perform productivity and costing analyses (e.g., calculate direct labor & materials costs for new products). • Support product transfer to additional manufacturing sites, if applicable. • 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 or advanced student in Biomedical Engineering, Mechanical Engineering or equivalent. · Between 0 - 1 years of experience in a medical device environment. · Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations. · 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 nontemperature controlled warehouse space. **Required Skills:** **Preferred Skills:**