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.
- Leads and/or participates in project teams coordinating the quality efforts of engineers, technicians and other professionals of various disciplines/departments to design, develop, and continuously improve medical device products. Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of a major project or in a total project of moderate scope.
- Performs work which involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of standard materials, and complex data analysis.
- Facilitating and performing internal QA audits.
- Supporting developmental projects in the area of quality assurance.
- Participates in product development teams.
- Analyzing reports and returned products and recommend corrective action, as required.
- Performing statistical analysis to assess cost of, and determine the responsibility for products or materials that do not meet required standards and specifications;
- Participate in MRB as appropriate.
- May specialize in one of the areas of in-process inspection, design of product evaluation, and/or research and development as they apply to quality control.
- Assists in and performs GMP training.
- Participates in the development of standard operating procedures.
- Prepares documentation for inspection/testing procedures.
- Performs responsibilities required by the Quality System and other duties as assigned or requested.
- Leads in the implementation of assurances, process controls, and CAPA designed to meet or exceed internal and external requirements.
- Establish effective corrective action plans, as required.
- Identify non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems, as required.
- Perform vendor Q.A. facility audits and administer any resultant corrective action programs, as required.
- Provides project direction, coaching, and mentoring for engineering and technical team personnel.
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
- Demonstrates and actively promotes highest levels of professional QA engineering discipline and rigor.
- Is an effective team member, fully motivated to achieve and demonstrate best practices in line with department objectives.
- Gives technical guidance to Quality Engineers, Associate Quality Engineers, technician and inspection staff.
- Works with EHS to identify significant environmental impacts of BSC-SH operations and to establish goals and targets around significant environmental impacts.
- Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise.
- May complete Design Assurance Quality Engineering tasks, typically one or more of the following:
- Participate, as required, in the development and qualification activities related to the platforms and breakthrough.
- Participate, as required, in the development and qualification activities related to initial product design and subsequent design changes.
- Designing and implementing methods and procedures for inspecting, testing and evaluating the precision and accuracy of products.
- Develop and validate measurement method.
- Monitoring design control standards to include (Assurance that new products meet guidelines, Performing related audits, develops success measurements and stays current with design control standards per FDA (ISO 9000) and industry standards);
- Determination of user needs for the design & subsequent translation into engineering requirements.
- Test methodologies to verify/validate the design performance, procedural use and design related risks.
- Verification & validation planning & execution.
- Successful implementation of design changes.
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
• 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.