Job Description
Johnson & Johnson Medical Devices Companies a member of Johnson & Johnson's Family of Companies is recruiting for a Manufacturing Engineer II. This position will be located in Santa Clara, California.
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.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
Key Role 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. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.
Required Skills - 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.
- 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.
Preferred Skills - Experience with ERP and MES (Oracle preferred)
Other: - The anticipated base pay for this position is $73,000.00 to $103,173.00.
- The anticipated travel for this position 10%
At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through innovative programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.
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 (
Job Tags
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