Process Development Engineer II Job in Spencer 47460, Indiana Us
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.
Process Development Engineer II
Job Description:
PURPOSE:
This position is responsible for the design and development of new and improved manufacturing processes and ensuring efficient and effective transfer of product into production.Core team member on a cross functional team and may also lead/manage derivative or design change projects of disposable medical devices.Looks to improve existing processes within the New Product Development project, that then may be shared across other lines.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Develop and implement new manufacturing processes for new disposable medical devices.Perform Design of Experiments for process definition and to optimize equipment parameters for new and/or existing processes.Create documentation to support new and improved manufacturing processes.Use of Six Sigma, Lean, and Mistake proof methodologies in the development of manufacturing processes to implement processes that are ‘born lean and capable’.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.Coordinate 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.Facilitate excellent communications between all team members.
Key Responsibilities:
Assesses process capabilities, innovates and implements process improvements on platform or derivative projects.
Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
Executes the functional deliverables associated with the PDP, Design Control, CAPA, and all Quality Systems.
As needed; plans, organizes, and participate all aspects of technical reviews.
Collaborate to ensures proper documentation is completed to meet quality systems requirements. (e.g., GOIs, BOM’s, Routers, FMEA’s, etc.)
Writes and reviews validation protocols and reports applicable to new processes.
Oversees development builds associated with the project using special work requests.
Develops and maintains qualified production lines.
Provides Design for Manufacturability (DFM) and lean manufacturing inputs to the engineering print package.
Contributes ideas to or generates Intellectual Property submissions.
Trains and/or provides work direction to technicians, and may train manufacturing personnel when required as part of a validation.
Serves as a core team member on new product projects.
Must comply with requirements of ISO 14001, Design Control, and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.
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.
Participates in cross-functional teams.
Collaborate to develop project planning, budgeting, scheduling and tracking.
Analyzes problems in design, process and test development.Recommend/implement solutions.
Ability to make and present engineering decisions.
Collaborate in all aspects of Design Transfer and launching new process into operations; operator training, line set up, inventory, material presentation, build scheduling, and transferring responsibility to the manufacturing engineering support team.
SUPERVISORY RESPONSIBILITIES:
May supervise or coach technicians or other support employees.Trains and/or provides work direction to technicians, 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 bachelors degree in science or BSME, MET, or related Engineering Degree and a minimum of three (3) years medical device experience in process/manufacturing engineering role.Must have excellent mechanical aptitude, communication and i
Minimum Education Required: Bachelor
Years of Experience Required: At Least 3 Years
Expected Travel Time: None
This company may offer relocation assistance.