Staff Manufacturing Engineer - Shockwave Medical

Johnson & Johnson•Santa Clara, CA

7d•Onsite

About The Position

Johnson & Johnson is hiring for a Staff Manufacturing Engineer - Shockwave Medical 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. 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 The Staff Manufacturing Engineer is responsible for designing, developing, testing, validating, and implementing processes, tooling, and fixtures for on-market products. The Staff Manufacturing Engineer will work closely with integration teams and serve as a core member of the team through successful implementation into the company’s manufacturing operations.

Requirements

Bachelor’s degree in Mechanical/Biomedical Engineering or equivalent experience
Minimum of eight (8) years of experience in a medical device environment or equivalent experience in other industries (pharmaceutical or automotive) that use the same principles of operation and similar regulations, or 5 years of experience with a Master’s Degree.
Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDR and other applicable regulations.
Experience and understanding Process Validations (IQ, OQ, PQ), 6S, Lean Manufacturing
Experience applying statistics and using statistical software, running Capability Studies (Cpk’s), and planning and analyzing DOE’s.
Experience with MES, ERP and/or PLM systems
Demonstrated proficiency in written and verbal communication, including creating and delivering presentations.
Ability to use special software such as: Solidworks, Minitab or closely 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.
Employee may be required to occasionally lift objects up to 25 lbs.

Nice To Haves

Accelerating
Coaching
Critical Thinking
Facility Management
Good Manufacturing Practices (GMP)
Lean Manufacturing Principles
Lean Supply Chain Management
Manufacturing Engineering
Performance Measurement
Product Design
Program Management
Project Engineering
Project Schedule
Risk Compliance
Robotic Automation
Safety-Oriented
Science, Technology, Engineering, and Math (STEM) Application
Technologically Savvy

Responsibilities

Work collaboratively with R&D, QA and Production departments to design, develop, test, document 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 analysis for components, manufacturing materials, packaging, and supplies used for in-house processing.
Lead effort to develop and maintains process Failure Modes and Effects Analyses (pFMEAs) for company processes.
Lead and/or actively participate in efforts to integrate new systems into the production environment.
Prepare user requirements, functional requirements, participate in validations, transfer of data from legacy systems and end user training.
Identify process requirements, advise and support operations management, and implement equipment and fixturing needed for process improvement and manufacturing efforts.
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 solving using DMAIC methodology.
Lead and/or actively participates in process/product improvement projects (in cooperation with production, R&D engineers and technicians).
Recommend new technologies to improve system performance and reliability.
Performs productivity and costing analyses (e.g., calculate direct labor, time studies& materials costs for new and existing products), providing solutions that improve efficiency and scalability for years to come.
Identify opportunities and implement cost reduction plans for existing products.
Support the transfer of product lines and the qualification-validation efforts.
Other duties as assigned.

Benefits

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

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