Apply for Quality Engineer - catheter

Opportunity: The Quality Engineer will be responsible for working as a part of a team, which ensures that all internal/external manufacturing projects meet all Quality system requirements. Perform engineering work requiring application of design of experiments, statistical techniques, Risk Management. Applies engineering practices and techniques to specific situations, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps or processes. Experience with Plastics, Molding and extrusion processes is a plus. Division Information: Our cardiac care product range includes technologically advanced left heart products for critically ill cardiac patients and right heart catheter products, including thermodilution and Berman cathethers, pacing catheters and transradial access products. Our line of balloon catheters and balloon pump consoles is the result of years of clinical and engineering expertise from multiple venues that have come together to bring to market innovative cardiac assist products for critically ill patients who require balloon pump support. In addition to options for balloon pump consoles, we also offer a wide array of intra-aortic balloon catheters with styles from firm to flexible and wire-reinforced catheter bodies to polyurethane. Position Description: Work with Management and team developing/ improving programs to ensure improved quality and reliability in products, and reduce the total cost of Quality including:

•Reliability studies •Customer complaints •Customer returns •Field service & repairs

Represent Quality Assurance through all product design and development life cycle phases to help ensure product manufacturability, reliability and cost effectiveness.

Responsible for writing and reviewing Non-Conformance Materials Review to verify discrepancy and adequacy of response to corrective action request.

Create documentation associated with engineering activities including:

•Quality Plans •Test method Verification & validation protocols/ reports •Update Quality System and Department procedures

Participate in product complaint investigations, root-cause analysis, and corrective and preventive actions

Key contributor in Corrective Action and Preventive Action (CAPA) System

Perform Quality System Internal Audits Responsible for Supplier Quality system in monitoring and auditing Requirements: Basic Qualifications:

•B.S. Degree in Mechanical Engineering preferred •Strong skill level in engineering principles (design of experiments, statistical data analysis, tolerance analysis, human factor engineering, FMEA/FTA, reliability, validation, development and execution of protocols/reports •Quality System Regulations knowledge (QSR 21 CFR part 820, ISO 14971, ISO 13485) •Medical Device Design Control knowledge and experience (IEC/UL 60601, MDD, CMDCAS) •Minimum of 5 years of experience in Quality Engineering, Medical Device preferred

Preferred Qualifications:

•Strong skill level on MS Word, Excel, Access, Power Point, Visio, Experience with Solidworks, CAD • Excellent verbal & written communication skills including presentations (internal & external customers) •Proven ability to interact successfully with all levels of the organization •Must possess high degree of organizational skills and be a self-starter • Ability to work in and contribute to a product development team and other team environments •Ability to plan and prioritize activities •Ability to work independently to meet assigned project deadlines