Process Development Engineering Technician III Job
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PRIMARY LOCATION: US-IN-Spencer
ADDITIONAL LOCATIONS: (n/a)
REQUISITION ID: 269878
Assist in the design and integration of New Technology for Endoscopic medical device applications. Work with your team to engineer innovation and lead the development of novel production processes and launch new products to transform patient lives.
At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In the Endoscopy division, we provide advance technologies for diagnosing and treating diseases of the digestive system, airway and lungs. Medical Conditions we provide solutions for include: Malignant & Benign Tumors, Gastrointestinal Diseases, Pulmonary Diseases, Gastrointestinal Cancers and Abscesses. We are able to provide a number of solutions to patients that include: Balloon Dilation, Stenting, ERCP/Cholangioscopy, Biliary, Biopsy and Polypectomy, Hemostasis, Radio Frequency Ablation and Enteral Feeding. We have a robust product line and pipeline, and we will continue to make an investment in Endoscopy treatments.
This role's primary commitment is to assist project teams in the development of new medical device products and their associated manufacturing processes. Primarily directed by engineers to create and refine the necessary machinery, tooling, documentation, and relationships to successfully bring these new products to market in a regulated industry.
Under the direction of a Process Development Engineer, support the development of :
- Create new manufacturing processes and techniques
- Create the testing methodologies and apparatus to evaluate product and process performance
- Assist in the development of product specifications
- Assist in the procurement of new testing and manufacturing equipment
- Create and update documentation such as TechnicalReports, Drawings and Operator Instructions, etc.
- Creating and implementating process and product qualification (IQ, OQ, PQ)
- Execute studies supporting the development of new process/ product specifications
- Utilize DOE and basic statistical analysis
- Take an active role in leading sub-projects in support of the overall project.
- Perform all activities within the boundaries of a regulated and auditable quality system
Record and document all projects, tasks and results per lab notebook/Spencer SOP's as well as QSR/ISO procedures.
Must comply with requirements of ISO 14001:2004 and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.
SUPERVISORY RESPONSIBILITIES: None
QUALITY SYSTEM REQUIREMENTS
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
- The position requires a minimum 2-year technical degree or equivalent experience.
- 5+ years' experience providing technical support in a product / process development or manufacturing environment.
- Must be proficient in MicroSoft Office software applications and have a demonstrated mechanical aptitude.
- CAD proficiency(Autocad and/or SolidWorks)
- Previous experience in a technology development / production environment, including implementing new/improved manufacturing processes, tool design/building and machine and process debugging.
- Experience in a mechanical lab using various testing machines and methods.
- Experience using SAP and PDM.
- Experience with Autocad and/or Solidworks.
- Experience completing and implementing significant portions of the following deliverables with minimal supervision via PDM change request submission/approval:
- Installation Qualification (IQ) documents (equipment specifications, equipment drawings, maintenance procedures, PFMEA's, change modification form environmental/health/safety evaluations, software validations, IQ protocols. . .etc)
- Operational/Performance Qualification documents (protocols, protocol reports, NSMR's. . .etc)
- Project implementation documents and operator training (SAP/PDM part numbers/routers/BOM's, GOI's, in-process inspection reports. . .etc)
- Recording and documenting all projects, tasks and results per lab notebook/Spencer SOP's as well as QSR/ISO procedures.
BOSTON SCIENTIFIC (NYSE: BSX) TRANSFORMS LIVES THROUGH INNOVATIVE MEDICAL SOLUTIONS THAT IMPROVE THE HEALTH OF PATIENTS AROUND THE WORLD. AS A GLOBAL MEDICAL TECHNOLOGY LEADER FOR MORE THAN 30 YEARS, WE ADVANCE SCIENCE FOR LIFE BY PROVIDING A BROAD RANGE OF HIGH PERFORMANCE SOLUTIONS THAT ADDRESS UNMET PATIENT NEEDS AND REDUCE THE COST OF HEALTHCARE. FOR MORE INFORMATION, VISIT US AT WWW.BOSTONSCIENTIFIC.COM
Boston Scientific is an Equal Opportunity Employer.
Posting Notes: US-IN-Spencer||(n/a)||Manufacturing & Operations||(n/a)
Nearest Major Market: Bloomington Indiana
Job Segment: Process Engineer, Engineer, CAD, Developer, Technician, Engineering, Technology