Johnson & Johnson
Sr Manufacturing Mechanical Engineer - Shockwave
Johnson & Johnson, Santa Clara, California, us, 95053
Overview
Johnson & Johnson is hiring for a
Sr. Manufacturing Engineer, Shockwave Medical
to join our team located in
Santa Clara, CA . 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. We are developing the next generation of smarter, less invasive, more personalized treatments, including the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. The 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 Senior Manufacturing Mechanical 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. This includes 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 Senior Engineer will assist in identifying and pursuing value improvement and cost improvement projects to support operations in line with business goals and objectives. Responsibilities
Act as the primary technical point of contact; work with contract manufacturers and external partners to transfer and scale Shockwave manufacturing processes. Support development transfer activities from R&D and Operations to contract manufacturers/suppliers. Collaborate with local and international suppliers and manufacturing sites to generate capacity/capability models and make vs. buy assessments for site planning. Prepare and execute validation protocols and complete validation reports. Develop and maintain process risk documentation (e.g., PFMEA) to identify potential risks and implement preventive and corrective actions. Prepare engineering change orders and coordinate implementation of changes including training production staff. Provide expertise in project planning, timeline development and management, and maintain project schedules. Implement and manage process improvement and cost reduction projects. Ensure capacity aligns with the manufacturing plan. Utilize lean manufacturing tools to continuously improve material and information flow in the factory (factory layouts, visual management, 6S, JIT, Kanban). Implement robust, cost-effective manufacturing processes to improve product flow, quality, and safety for sustained and new products. Collaborate with cross-functional teams during development and provide input for design for manufacturability (DFM). Develop, test, and implement tools, fixtures and equipment for manufacturing processes. Support improvements for mechanical equipment features such as 3D Printing, UL impact testing, and material selection. Develop manufacturing process instructions, inspection plans, and lot history travelers. Perform analysis for cost reduction and quality/efficiency improvements. Lead design transfer of new products to production, including assembly time and yield targets, training needs, and quality control. Assist suppliers in product failure investigations to determine root cause and implement containment and corrective actions. Comply with FDA regulations, ISO requirements, company policies, procedures, and task assignments. Perform other responsibilities as assigned. Qualifications
Bachelor’s degree in Mechanical Engineering or related field. 5 years of experience in process/manufacturing development to launch for high-volume medical devices and transfer of product lines externally. Strong problem solving and analytical skills; experience with statistical analysis and design of experiments. Excellent organizational, verbal, and written communication skills with attention to detail. Experience with lean manufacturing, design for manufacturability, and test implementation. Experience with balloon/stent catheter manufacturing. Experience with braiding, coiling & laser processing operations a plus. Proficient with SolidWorks a plus. Ability to interface with all levels and functions of the organization; cooperative, team-balanced approach. Experience in regulated environments (ISO, FDA, cGMP) and knowledge of QSRs and related regulations. Experience in program management using tools like Gantt charts or Smartsheet. Proficiency in statistics (CpK, hypothesis testing, DOE, Gage R&R) a plus. Must be able to lift up to 25 lbs and travel internationally to oversee implementation and qualification activities. Additional Information
The anticipated base pay range for this position is $89,000 to $142,600 annually. Compensation includes an annual performance-based bonus and competitive benefits as described in the company programs. Eligible benefits include medical, dental, vision, life insurance, disability, and other plans; retirement and time-off benefits are provided as described in company materials. Time off includes vacation, sick time, holiday pay, and personal/work time as applicable by location. Additional information can be found at the company careers page for employee benefits. The compensation and benefits information applies to candidates hired in the United States; other locations follow local market practices. Note: This job description is not all-inclusive and the employee may perform other related duties as assigned. This job posting is anticipated to close on March 11, 2025; the company may extend this time period and will keep the posting active on the careers site. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees, please visit the company careers site.
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Johnson & Johnson is hiring for a
Sr. Manufacturing Engineer, Shockwave Medical
to join our team located in
Santa Clara, CA . 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. We are developing the next generation of smarter, less invasive, more personalized treatments, including the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. The 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 Senior Manufacturing Mechanical 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. This includes 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 Senior Engineer will assist in identifying and pursuing value improvement and cost improvement projects to support operations in line with business goals and objectives. Responsibilities
Act as the primary technical point of contact; work with contract manufacturers and external partners to transfer and scale Shockwave manufacturing processes. Support development transfer activities from R&D and Operations to contract manufacturers/suppliers. Collaborate with local and international suppliers and manufacturing sites to generate capacity/capability models and make vs. buy assessments for site planning. Prepare and execute validation protocols and complete validation reports. Develop and maintain process risk documentation (e.g., PFMEA) to identify potential risks and implement preventive and corrective actions. Prepare engineering change orders and coordinate implementation of changes including training production staff. Provide expertise in project planning, timeline development and management, and maintain project schedules. Implement and manage process improvement and cost reduction projects. Ensure capacity aligns with the manufacturing plan. Utilize lean manufacturing tools to continuously improve material and information flow in the factory (factory layouts, visual management, 6S, JIT, Kanban). Implement robust, cost-effective manufacturing processes to improve product flow, quality, and safety for sustained and new products. Collaborate with cross-functional teams during development and provide input for design for manufacturability (DFM). Develop, test, and implement tools, fixtures and equipment for manufacturing processes. Support improvements for mechanical equipment features such as 3D Printing, UL impact testing, and material selection. Develop manufacturing process instructions, inspection plans, and lot history travelers. Perform analysis for cost reduction and quality/efficiency improvements. Lead design transfer of new products to production, including assembly time and yield targets, training needs, and quality control. Assist suppliers in product failure investigations to determine root cause and implement containment and corrective actions. Comply with FDA regulations, ISO requirements, company policies, procedures, and task assignments. Perform other responsibilities as assigned. Qualifications
Bachelor’s degree in Mechanical Engineering or related field. 5 years of experience in process/manufacturing development to launch for high-volume medical devices and transfer of product lines externally. Strong problem solving and analytical skills; experience with statistical analysis and design of experiments. Excellent organizational, verbal, and written communication skills with attention to detail. Experience with lean manufacturing, design for manufacturability, and test implementation. Experience with balloon/stent catheter manufacturing. Experience with braiding, coiling & laser processing operations a plus. Proficient with SolidWorks a plus. Ability to interface with all levels and functions of the organization; cooperative, team-balanced approach. Experience in regulated environments (ISO, FDA, cGMP) and knowledge of QSRs and related regulations. Experience in program management using tools like Gantt charts or Smartsheet. Proficiency in statistics (CpK, hypothesis testing, DOE, Gage R&R) a plus. Must be able to lift up to 25 lbs and travel internationally to oversee implementation and qualification activities. Additional Information
The anticipated base pay range for this position is $89,000 to $142,600 annually. Compensation includes an annual performance-based bonus and competitive benefits as described in the company programs. Eligible benefits include medical, dental, vision, life insurance, disability, and other plans; retirement and time-off benefits are provided as described in company materials. Time off includes vacation, sick time, holiday pay, and personal/work time as applicable by location. Additional information can be found at the company careers page for employee benefits. The compensation and benefits information applies to candidates hired in the United States; other locations follow local market practices. Note: This job description is not all-inclusive and the employee may perform other related duties as assigned. This job posting is anticipated to close on March 11, 2025; the company may extend this time period and will keep the posting active on the careers site. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees, please visit the company careers site.
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