Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance
At Boston Scientific, well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, well help you in advancing your skills and career. Here, youll be supported in progressing whatever your ambitions.
About This Role:
This Quality Engineer role offers an employee the opportunity to be part of the Cardiac Rhythm Management Complaint Investigation Site within the Post Market Quality Assurance team at Boston Scientific. The primary activity for this role is to support analysis of investigations into field complaint allegations against Boston Scientific products. This position is a vital part of improving patient care by ensuring Boston Scientific device allegations are investigated efficiently and effectively.
Your Responsibilities Will Include:
* Assumes a technical role within the Complaint Investigation Site by using technical expertise and knowledge to support current and new market released technology
* Assists Senior level engineers in projects to enhance the ability to perform various complaint investigations
* Maintains knowlegde of state-of-the-art principles and strategies in their particular area of expertise.
* Participates in technical strategy planning for Boston Scientific
* Assists Lab Technicians during complaint investigations to ensure accurate and compliant product analysis and documentation
* Reviews completed returned product analysis results to ensure field allegations are adequately addresses
* Analyze returned products to address complaints and to ensure a high level of product quality
* May be asked to engage in projects/project plans outlining work plans including timelines, roles and resources; Identifies and leads cross-functional project teams comprised of functional experts and local managers
* Communicate product quality issues to Senior Engineers and/or Management for awareness to cross functional areas including Research and Development, Supplier Quality and Manufacturing
* Participates in cross functional teams to resolve quality issues
* Interprets complex technical issues for a non-technical audience
* Provides technical support for regulatory and legal inquiries
* Assists in developing novel methods to effectively analyze product complaints
* Performs a variety of duties in the electrical, mechanical, electro-mechanical, chemical, or optical areas
* Supports and/or performs Product Performance Engineering activities (trending, non-product return investigation analysis, etc.) during complaint investigation processing
* Responds to Technical Service Requests to support urgent questions from the Technical Service Team regarding product performance issues of devices being utilized in the field
* Serve as a support role for other activities within in the Complaint Investigation Site as needed
What We're Looking For In You:
Minimum Qualifications
* BS with 2-4 years of relevant experience
* Understanding and a command of highly technical engineering topics
* Ability to independently manage project work to define delivery dates
* Understanding and experience operating within the quality system processes and procedures
* Critical thinking, problem solving, and troubleshooting ability
* Strong communication (verbal and written) and data analysis skills
Preferred Qualifications
* Engineering degree with 2-4 years of relevant experience
* A strong technical understanding of CRM products and device therapy
* Strong Technical Writing skills
* Strong understanding of the Quality System and experience with the post-market quality function and/or systems
* Experience interacting with Medical Safety, Design Assurance, R&D, Return Product Analysis, Supplier Development and/or Manufacturing
* Experience supporting competent authority responses
Requisition ID: 476434
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isnt just business, its personal. And if youre a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
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)