Johnson & Johnson is recruiting for Manufacturing Engineer I for Shockwave Medical Inc. located in Santa Clara, CA.
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Shockwave Medical, Inc. 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 Manufacturing Engineer II is responsible for providing engineering support to Production. Also responsible for designing, developing, testing, and implementing processes, tooling, and fixtures for commercial product. In addition, the Manufacturing Engineer II will sustain activities on the production line such as raw material, process and equipment issues.
Essential Job Functions
- Actively collaborate with Production to provide sustaining support in resolving product/process/equipment problems.
- Actively identify and participate in process/product, tooling, equipment, fixtures and cost reduction improvement projects.
- Coordinate and/or perform functional and destructive testing to support Engineering Reports. Document the results and provide a statistical analysis using Minitab or excel.
- Participate as an extended team member for new product introduction, including scaling up, stabilizing and transfer to alternate sites.
- Participate in development and maintenance of process FMEAs, Manufacturing Process Instructions (MPIs), and Device Master Record (DMR) documents.
- Create, maintain and transfer paper Bill of Materials (BOM's) and Lot History Records (LHR's) into Item Structures, Work Definitions and electronic LHR's.
- Support efforts to resolve Quality related events (NCR, CAPA, Audit Finding) and maintain other Quality System Requirements.
- Create and release label files used for printing product labels.
- Create and execute process validation protocols and reports.
- 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.
Qualifications
Requirements
- Bachelor's degree in Engineering.
- 3-5 years of experience in a medical device environment.
- Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable regulations.
- Understanding of Lean and Six Sigma concepts.
- Experience with Validation of Medical Devices (IQ-OQ-PQ).
- Basic understanding of Statistics (Cpk, Hypothesis Testing, DOE's, Gage R&R) a plus.
- Able to create and maintain Drawings in SolidWorks.
- Experience with ERP and MES (Oracle preferred)
- 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 lift objects up to 25lbs or more. Employee will be required to work in an air-conditioned Class 8 Cleanroom.
Market Range: $86,000 - $107,000
Exact compensation may vary based on skills, experience, and location.
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.
The anticipated base pay range for this position is $61,000 to $97,750.
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.
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on January, 8, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.