Johnson & Johnson MedTech · 1 day ago
Staff Supplier Engineer
Santa Clara, CA
Full-time
Onsite
Lead/Staff
$125K/yr - $169K/yr
8+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, focusing on developing smarter and less invasive treatments. The Staff Supplier Engineer will provide technical support to contract manufacturers and suppliers, ensuring the successful implementation and validation of manufacturing lines for Shockwave products, while also driving process improvements and cost reduction projects.
Hospital & Health Care
Responsibilities
Acts as the primary technical point of contact; works with our contract manufacturer and external partner to transfer and scale Shockwave manufacturing process
Support supplier selection and qualification to support Global business continuity initiatives
Supports development transfer activities from R&D & Operations to contract manufacturer/suppliers
Lead local, international suppliers and manufacturing sites to generate capacity/capability models and make vs. buy assessments used as an input to site planning
Manage preparation and execution of validation protocols and completion of validation reports
Develops and maintains process risk documentation (e.g., PFMEA) to identify potential risks and implement preventive and corrective actions
Provides expertise in project planning and timeline development & management and maintain project schedules and timelines
Lead & Implements process improvement and cost reduction projects
Effectively utilizes lean manufacturing tools for continuously improving the flow of material and information in the factory including factory layouts, visual management, 6S, JIT, Kanban
Implement robust cost-effective manufacturing processes and improve product flow and product quality and safety performance for both sustained and new products
Collaborates with cross-functional teams during development phase(s) and provides inputs and recommendations for design for manufacturability (DFM)
Develops, tests, and implements tools, fixtures and equipment required for manufacturing processes
Develops manufacturing process instructions, inspection plans and lot history travelers
Performs analysis for cost reduction, and quality and efficiency improvement
Leads design transfer of new products to production including establishing assembly time and yield targets, training needs and quality control
Assists suppliers in product failure investigations required to determine root cause, improve product reliability, performance improvement as well as effective containment and counter measures
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments
Performs other responsibilities and duties as assigned
Qualification
Required
Bachelor's degree on Mechanical Engineering or related field
Minimum of eight (8) years of experience in all phases of Process/Manufacturing development to launch for high volume commercial or medical devices and transfer of product lines externally, or 6 years of experience with a Master's Degree
Strong problem solving and analytical skills; experience with use of statistical analysis and design of experiments for product optimization and validation activities
Excellent organizational, verbal, and written communication skills as well as attention to detail
This position will require occasional travel abroad to oversee the implementation process and the qualification-validation efforts
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
Able to interface with all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome
Experience working in regulated product and manufacturing environments (ISO, FDA, cGMP)
Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements.) and other applicable regulations
Experience in Program Management, use of Gantt Charts or Smartsheet
Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus
May be required to occasionally lift objects up to 25lbs
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 MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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