Johnson & Johnson is hiring for a Senior Manufacturing Mechanical Engineer - Shockwave Medical to join our team located in Santa Clara, CA.
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Shockwave Medical, Inc., recently acquired by Johnson & Johnson, is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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 Senior Manufacturing Mechanical 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 Senior Manufacturing and Transfer Engineer will 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.
- Supports development transfer activities from R&D & Operations to contract manufacturer/suppliers.
- Works with local, international suppliers and manufacturing sites to generate capacity/capability models and make vs. buy assessments used as an input to site planning.
- Responsible for 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.
- Prepares engineering change orders and coordinates the implementation of changes including training production staff.
- Provides expertise in project planning and timeline development & management and maintain project schedules and timelines.
- Implements and manage process improvement and cost reduction projects.
- Ensures capacity is appropriate for the manufacturing plan.
- 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.
- Support improvements for mechanical equipment features like 3D Printing, UL Impact testing, and Material selection.
- 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.
Qualifications
- Bachelor's degree on Mechanical Engineering or related field.
- 5 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.
- 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.
- 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.
- Must be able to lift objects up to 25lbs.
- Must be able to travel abroad to oversee the implementation process and the qualification-validation efforts.
Additional Information:
- The anticipated base pay range for this position is $89,000 to $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. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.