Johnson & Johnson
Sr Manufacturing Engineer NPI Shockwave
Johnson & Johnson, Santa Clara, California, us, 95053
Overview
Johnson & Johnson is hiring for a Sr. Manufacturing Engineer (NPI) to join our team located in Santa Clara, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments, including the development and commercialization of Intravascular Lithotripsy (IVL) for 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. Job Details
Job Function:
Supply Chain Engineering Job Sub Function:
Manufacturing Engineering Job Category:
Scientific/Technology All Job Posting Locations:
Santa Clara, California, United States of America Position Overview:
The Senior Manufacturing Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle, from design to production. The Senior Manufacturing Engineer will work closely with production, quality, and R&D teams to support the company’s manufacturing operations and product launch timelines. Essential Job Functions
Work collaboratively with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures. Support and work with Quality to address and resolve non-conformances. Collect data and analyze process performance and capabilities for company products, including new products and products already in production. Identify process requirements, advise and support operations management, and implement equipment and fixtures needed for process development and manufacturing efforts. Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, and other Quality System requirements. Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology. Lead and/or actively participate in process/product continuous improvement projects (in cooperation with development engineers and technicians). Apply Lean manufacturing principles in production processes to reduce/eliminate waste and increase productivity. Assist Procurement and R&D 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 Engineering. Minimum 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 (e.g., traceability QSRs, ISO and MDD requirements). Experience implementing Lean and Lean Sigma concepts. Experience with Validation of Medical Devices (IQ-OQ-PQ). Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus. Ability to use special software such as: Solidworks, Minitab or related. 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. May be required to occasionally lift objects up to 25lbs. Additional Information
The anticipated base pay for this position is $105,400 - $142,600 annually. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below: Career benefits information will be provided during the application process. 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, disability, protected veteran status or other characteristics protected by federal, state or local law. Veterans and individuals with disabilities are encouraged to apply.
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Johnson & Johnson is hiring for a Sr. Manufacturing Engineer (NPI) to join our team located in Santa Clara, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments, including the development and commercialization of Intravascular Lithotripsy (IVL) for 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. Job Details
Job Function:
Supply Chain Engineering Job Sub Function:
Manufacturing Engineering Job Category:
Scientific/Technology All Job Posting Locations:
Santa Clara, California, United States of America Position Overview:
The Senior Manufacturing Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle, from design to production. The Senior Manufacturing Engineer will work closely with production, quality, and R&D teams to support the company’s manufacturing operations and product launch timelines. Essential Job Functions
Work collaboratively with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures. Support and work with Quality to address and resolve non-conformances. Collect data and analyze process performance and capabilities for company products, including new products and products already in production. Identify process requirements, advise and support operations management, and implement equipment and fixtures needed for process development and manufacturing efforts. Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, and other Quality System requirements. Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology. Lead and/or actively participate in process/product continuous improvement projects (in cooperation with development engineers and technicians). Apply Lean manufacturing principles in production processes to reduce/eliminate waste and increase productivity. Assist Procurement and R&D 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 Engineering. Minimum 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 (e.g., traceability QSRs, ISO and MDD requirements). Experience implementing Lean and Lean Sigma concepts. Experience with Validation of Medical Devices (IQ-OQ-PQ). Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus. Ability to use special software such as: Solidworks, Minitab or related. 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. May be required to occasionally lift objects up to 25lbs. Additional Information
The anticipated base pay for this position is $105,400 - $142,600 annually. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below: Career benefits information will be provided during the application process. 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, disability, protected veteran status or other characteristics protected by federal, state or local law. Veterans and individuals with disabilities are encouraged to apply.
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