Manufacturing Engineer II - Shockwave

About the position

Johnson & Johnson is hiring for a Manufacturing Engineer II - Shockwave Medical to join our team located in Santa Clara, CA. 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.

Responsibilities

• 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.

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.
• 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.
• Experience with MES and ERP (Oracle) preferred.
• 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.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Consolidated retirement plan (pension) and 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.