Johnson & Johnson · 1 day ago
Staff Manufacturing Engineer - Shockwave Medical
Santa Clara, California, United States of America
Full-time
Onsite
Lead/Staff
$109K/yr - $175K/yr
8+ years expJohnson & Johnson is a global leader in healthcare innovation, and they are seeking a Staff Manufacturing Engineer to join their team at Shockwave Medical. The role involves designing, developing, testing, and implementing manufacturing processes and tooling for medical devices, specifically focusing on Intravascular Lithotripsy treatments.
Hospital & Health Care
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. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel
Qualification
Required
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
Preferred
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
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
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
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
Company data provided by crunchbase