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Quality Engineer II Job

Date: Mar 18, 2017

Location: Menlo Park, CA, US

Company: Boston Scientific

Primary Location: US-CA-Menlo Park
Additional Locations: (n/a)
Requisition ID: 296376

At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. 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. We have a robust product line and pipeline, and we will continue to make an investment in interventional treatments.

Candidate will be a member of the team tasked with increasing capacity of manufacturing for components and sub-assemblies for the Lotus Heart Valve family of products. The candidate will have the opportunity to participate in new equipment/process automation projects, new process development/validation efforts, and value improvement projects.

Purpose Statement

To develop and implement 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 situation or data requires a review of identifiable factors. Exercise judgment and practices to determine appropriate action. Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work. Develop, establish and maintain quality engineering methodologies, systems, and practices which meet BSC-SH, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.

Key Responsibilities

- Participate in the development and qualification activities related to the derivative products, platforms and breakthrough.
- Participates in the development of testing and inspection methodology and documentation for new and existing products.
- Designs and installs QC process sampling systems, procedures, and statistical techniques.
- Designs or specifies inspection and testing mechanisms and equipment.
- Performs failure analyses and defect investigations.
- Analyzes production limitations and standards.
- Recommends revision of specifications.
- Interfaces with other engineering departments within the company, customers, and suppliers on quality related issues.
- Participates in the development of standard operating procedures.
- Performs responsibilities required by the Quality System and other duties as assigned or requested.
- Continually seeks to drive improvements in product and process quality.
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Complete Design Assurance related activities, as required:
- Participate in the development and qualification activities related to the initial product design and subsequent design changes.
- Develops, coordinates the execution of, and creates the reports for test protocols used for Design Verification, Validation, and general engineering use.
- Participates in the development and maintainence of the product risk management documents.

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.

Basic Qualifications:

- 2-4 Years Relevant Experience with BS, 0-2 Years with MS
- Experience leading or partcipating 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. Experience planning, scheduling, conducting or coordinating detailed phases of the engineering work in a part of a major project or in a total project of moderate scope.
- Has performed 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.
- Experience giving technical guidance to Quality Engineers, Associate Quality Engineers, technician and inspection staff.

- Ability to travel locally, domestically and internationally as needed

Preferred Qualifications:
- Experience with EDM (Electro Discharge Machining) highly desirable

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.

Posting Notes: US-CA-Menlo Park||(n/a)||Quality||(n/a)

Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland

Job Segment: Quality Engineer, Manufacturing Engineer, Product Development, Machinist, Quality, Engineering, Research, Manufacturing