Additional Locations: (n/a); US-IN-Evansville; US-IN-Fort Wayne; US-IN-Gary/Merrillville; US-IN-Indianapolis; US-IN-Lafayette; US-IN-South Bend; US-IN-Spencer; US-IN-Terre Haute
Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
About the role:
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.
You're responsibilities will include:
- 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.
- Work the lifetime of the products which includes supporting the Process Development team and then transitioning back to the Manufacturing team role and responsibilities.
- Write and perform process validations (IQ, OQ, PQ, PPQ) and validate methods for inspection for verification and process controls.
- Interface directly and support 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 and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.
- May Supervise or coach technicians or other engineering support employees
What we're looking for in you:
- The position requires a BSME, MET, or related Engineering Degree and a minimum of 5 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)
- Previous supervisory experience preferred.
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 468419