At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. In Interventional Cardiology (IC) we design, develop, and produce technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. Medical conditions we provide solutions for include: cardiovascular diseases, coronary artery disease, acute myocardial infarction. We are able to provide a numberof solutions to patients that include: drug-eluting stents, bare-metal stents, catheters, balloons, guide wires, coronary atherectomy and coronary intravascular ultrasound.
As a fully qualified engineer, plans and conducts work requiring judgment in the independent evaluation, selection and substantial adaptation and modification of standard techniques, procedures, and criteria. Devises new approaches to problems encountered. Engineering specialities may include the development, application, revision, and maintenance of quality standards for processing materials into partially finished or finished products; assessment , control, application of risk and verification/validation methodologies for product design and design changes and monitoring of design control and for providing quality assurance support to the company.
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.
• Bachelor of Science degree in a technical discipline, graduate degree preferred. • Minimum of 5 years' experience in a medical device regulated environment, knowledge of FDA and ISO13485 regulatory requirements and be able to explain how to apply Quality System in a Manufacturing and Design environmen
Preferred Qualifications: • Must be detailed in handling information/data and able to draw conclusions with sound logic. • Knowledge of FDA GMP/GLP, Medical Device Directive and ISO.
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.
Boston Scientific is an Equal Opportunity Employer.