<p>Duties and Responsibilities: Participate in the development and improvement of manufacturing processes for SmartValve Manufacturing and catheter-based systems in accordance with FDA and international regulations.</p> <ul> <li>Evaluate, develop, and sustain processes to meet product performance and manufacturing yield requirements. </li><li>Constantly identify opportunities to reduce cycle time and waste. Develop and implement plans to capitalize on these opportunities. </li><li>Evaluate and modify process flow as necessary to improve efficiency. </li><li>Develop tools, fixtures, and processes to meet product and process capability requirements. </li><li>Create and maintain process validation master plan. Develop, qualify, and validate new manufacturing processes as needed. </li><li>Manage activities with outside vendors that provide components, assemblies, manufacturing processes, testing, and other services. </li><li>Build and validate test equipment, conduct testing of product, and analyze data as needed. </li><li>Follow approved procedures for activities conducted and update or generate new procedures as needed. </li><li>May supervise operators, technicians, or other engineers. </li><li>Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485. </li><li>Assure individual and group safety when conducting all activities. </li><li>Maintain effective communications with supervisor and peers in project activities. </li><li>As necessary, suggest strategic direction for specific projects. </li><li>Support day-to-day manufacturing activities. </li><li></li></ul> <p>Qualifications</p> <p>Education & Certifications:</p> <ul> <li>Minimum of four-year engineering degree or equivalent experience. </li></ul> <p>Work Experience:</p> <ul> <li>0-2 years experience in a medical device manufacturing environment is required. </li></ul> <p>Knowledge, Skills & Abilities:</p> <ul> <li>Cardiovascular catheter experience preferred; will consider candidates with self-expanding stent experience. </li><li>Knowledge with chemistry and good laboratory practices. </li><li>Familiarity with Six Sigma principles preferred. </li></ul> <p>Physical Requirements:</p> <ul> <li>Able to work in an industrial environment. </li></ul>