Staff Supplier Engineer

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Johnson & Johnson is hiring for aStaff Supplier Engineer - Shockwave Medicalto join our team located inSanta Clara CA.

Position Overview

The Staff 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. Including 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 Staff Manufacturing Engineerwill assist in the identification and pursuit of value improvement and cost improvement projects to support operations in line with business goals and objectives.

Essential Job Functions

• 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 performanceimprovement 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.

Requirements

• Bachelors 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 Masters 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 ( 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.

NOTE: This job description is not intended to be all-inclusive. Employees may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.

Additional Information

• The anticipated base pay range for this position is $124950 to $169050 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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys 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. Skills:

  Preferred Skills:

  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 Scheduling Risk Compliance Robotic Automation Safety-Oriented Science Technology Engineering and Math (STEM) Application Technologically Savvy

  The anticipated base pay range for this position is :

  Additional Description for Pay Transparency: