Additional Locations: (n/a)
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, were solving some of the most important healthcare industry challenges. Together, were one global team committed to making a difference in peoples lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your lifes work.
About the role:
Develop, implement, maintain and improve appropriate quality system elements to ensure the high quality level of new and existing products. Works with problems of moderate scope where the analysis of a situation or data requires a review of identifiable factors.
Your responsibilities include:
* Provides Quality Engineering support:
* Analysis of complaint returns related to Capital Equipment (Electronic Hardware/Software/Firmware) and approval of analysis performed by others
* Coordinates and supervises failure investigation activities of lab technicians
* Collects, analyzes and trends complaint data for other groups including upper management
* Monitors product performance thru sound statistical methods and tools (SPC, Excel, SAS, Paretos, FMEA, Control Charts, etc.)
* Creates slides for product performance and presents to upper management
* Collaborates with other company sites, participates and leads global projects related to Post Market / Complaints
* Creates, releases new WI/SOPs in document control system
* Initiates and owns non-conformance investigations and CAPAs
* Proactively investigate, identify, and implement Quality System improvements.
* Provide leadership role in championing departmental or cross-functional engineering initiatives
* Provide project direction, coaching, and mentoring for engineering and technical team personnel
What were looking for:
Qualifications
* BS Degree or higher degree in electrical or computer engineering
* Minimum of 2 years work experience related to failure analysis of capital equipment systems with electroinc hardware / software / firmware to root cause and component level
* Advanced level knowledge of databases and data analysis tools (SAS, SQL, Excel, etc.) is preferred
* Working knowledge of statistics and data analysis tools (SAS, SQL, Excel, etc.) is preferred
* Understanding of medical device regulations is preferred
* Great communication and organization skills
About us
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 youre looking to truly make a difference to people both around the world and around the corner, theres no better place to make it happen.
Requisition ID: 475862
Marlborough, MA
Boston Scientific Corporation, doing business as Boston Scientific, is a manufacturer of medical devices used in interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynecology.
Boston Scientific is primarily known for the development of the Taxus Stent, a drug-eluting stent which is used to open clogged arteries. With the full acquisition of Cameron Health in June 2012, the company also became notable for offering a minimally invasive implantable cardioverter-defibrillator (ICD) which they call the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD)