Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Manufacturing Engineer I
Description
PURPOSE:
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 sub-sections of a project.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Perform Six Sigma (Problem Solving and Process Improvement) and Lean tools to develop project opportunities to gain rates of improvement from manufacturing lines. Utilize Design of Experiments to optimize processes. Create documentation to support new and improved manufacturing processes. Write and perform process validations (IQ, OQ, PQ, PPQ) and validate methods for inspection for verification and process controls. 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.
Key Responsibilities:
1. Assesses process capabilities and innovates and implements process improvements on commercial products.
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, Strategic Initiative, and Quality Systems.
4. Ensures proper documentation is completed to meet quality systems requirements. (e.g., GOI, BOM’s, Routers, FMEA’s, etc.)
5. Writes and reviews validation protocols and reports applicable to new processes.
6. Oversees development builds associated with the project using special work requests.
7. Develops and maintains qualified production lines.
8. Provides Design for Manufacturability (DFM) input to the engineering print package.
9. Contributes ideas to or generates Intellectual Property submissions.
10. Trains and/or provides work direction to technicians and may train manufacturing personnel when required as part of a validation.
11. Participate in lean reviews, line side meetings, and Kaizen events.
12. Must comply with requirements of ISO 14001 and BSC Environmental , Health and Safety standards and follow procedures and instructions related to these standards.
13. Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.
SUPERVISORY RESPONSIBILITIES:
May supervise or coach technicians or other engineering support employees. Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation.
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: To be considered for this position you must have the following qualifications: EDUCATION, EXPERIENCE, and/or SKILLS
The position requires a Bachelor’s degree in engineering or a related discipline. Must have excellent mechanical aptitude, communication and interpersonal skills. Must be experienced in MS word, Excel and Project.
PREFERRED REQUIREMENTS: The following are qualifications that we would prefer candidates to have.
The ideal candidate will have previous experience in the areas of Design for Manufacturing (DFM), Lean Manufacturing, and Process Control Concepts, Design of Experiments (DOE), Software Validation and product/process Failure Mode and Effects Analysis (FMEA). Use of Problem Solving and Process Improvement Methodologies (e.g. 6 Sigma), and managing improvements through CAPA. Experience with CAD Software (Solid Works & AutoCAD) preferred.
