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.
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 complex projects independently with minimal supervision.
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.
- Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on commercial products.
- Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
- Executes the functional deliverables associated with the CAPA, VIP, Strategic Initiative, and Quality Systems.
- Plans, organizes, and conducts all aspects of technical reviews.
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., GOI’s, 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) input to the engineering print package.
- Contributes ideas to or generates Intellectual Property submissions.
- Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation.
- May serve as a core team member or extended team member on new product projects.
- Participate in lean reviews, line side meetings, and Kaizen events.
- Must comply with requirements of ISO 14001:2015 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 the 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
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 BSME, MET, or related Engineering Degree and a minimum Six (6) years medical device experience in a process/manufacturing engineering role. Must have excellent mechanical aptitude, communication and interpersonal skills. Must be experienced in 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) and previous supervisory experience preferred.
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/Affirmative Action Employer