Manufacturing Engineer II Job
Job Code - 41178
Position - See job description
Job First Active on: Thursday, February 16, 2012
Manufacturing Engineer II
Develop and implement manufacturing business improvement projects and processes for disposable medical devices. Support teams to make improvements to existing devices and manufacturing processes. Lead less complex projects independently with minimal supervision.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Perform Design of Experiments to optimize processes. Create documentation to support new and improved manufacturing processes. Write and perform process validations (IQ, OQ, PQ). Interface directly with assemblers, production supervisors, leads, engineers and management daily. Coordinates with the suppliers and external resources needed in developing and implementing new process/product plans.
Work as part of a development team in developing and implementing new devices.
1. Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects.
2. Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
3. Executes the functional deliverables associated with the CAPA, VIP- Project Management, and Quality Systems.
4. Plans, organizes, and conducts all aspects of technical reviews.
5. Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.)
6. Writes and reviews validation protocols and reports applicable to new processes.
7. Oversees development builds associated with the project using special work requests.
8. Develops and maintains qualified production lines.
9. Provides Design for Manufacturability (DFM) input to the engineering print package.
10. Contributes ideas to or generates Intellectual Property submissions.
11. Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation.
12. May serve as a core team member or extended team member on new product projects.
13. Participate in lean reviews, line side meetings, and Kaizen events.
14. Must comply with requirements of ISO 14001 and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.
15. Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System, and appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.
May supervise or coach technicians or other engineering support employees.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
MINIMUM REQUIREMENTS: EDUCATION, EXPERIENCE, and/or SKILLS
The position requires a Bachelor’s degree in engineering or a related discipline and a minimum of three years medical device experience in a process/manufacturing engineering role. Must have excellent mechanical aptitude, communication and interpersonal skills. Must be experienced in Microsoft Office applications including MS word, Excel and Project.
The ideal candidate will have previous experience in the areas of Design for Manufacturing (DFM), Design of Experiments (DOE) and product/process Failure Mode and Effects Analysis (FMEA), Experience with CAD Software (Solid Works & AutoCAD)
REQUIREMENTS - QUALIFICATIONS: Manufacturing Engineer II
See job description above
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