Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of Edwards’ innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will enable you to optimize product development to impact patients around the world with pioneering technology.Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.This Pilot Operations Quality Engineer II role starts with the opportunity to partner on the development of delivery systems for transcatheter heart valves on clinical manufacturing lines for the Transcatheter Heart Valve (THV) Business Unit as a part of Edwards Global Supply Chain. This cross functional partner will (1) interact with various functional departments to accomplish compliance and implementation of quality goals with a primary focus to lead quality operations for Pilot manufacturing, (2) work with THV new product development teams in the manufacturing of products for development testing and clinical studies as well as (3) support product transfer from Pilot manufacturing to receiving site manufacturing facilities.How you will make an impact:· Work with new product development teams to help them efficiently navigate the Edwards' Quality System in order to build quality system test samples and human use product according to project schedules· Investigate moderately complex manufacturing product quality and compliance issues (e.g., non-conformances, CAPA, audit observations) for production processes prior to final product release based on engineering principles: analyze results, make recommendations and develop reports· Optimize moderately complex manufacturing processes for design for manufacturing and for continuous process improvement. Identify opportunities to improve manufacturing processes and reduce risk. Drive improvements for inspection methods.· Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of manufacturing processes· Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Manufacturing Process Reviews)· Support test method validation activities for in-process inspections· Facilitate Material Review Board to disposition potentially non-conforming human use products· Track product yields and defect rates. Use data to report metrics at Quality Data Reviews and drive process improvementsWhat you'll need (Required):· Bachelor's Degree in relative Engineering field plus two (2) years industry experience· Master's Degree in relative Engineering field plus one (1) year industry experience· Ph.D. in Engineering field with relative thesis, post doctorate research or technical engineering rotation experienceWhat else we look for (Preferred):· Prior experience in medical device manufacturing or operations· Experience with computerized Manufacturing Execution System (MES)· Strict attention to detail· Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering· Solid problem-solving, organizational, analytical and critical thinking skills· Exhibits professional communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management· Basic knowledge of statistical techniques and analytics (experience in Minitab preferred)· Ability to manage competing priorities in a fast-paced environment· Thrives in a collaborative team environment, including inter-departmental teams and key contact representing the organization on contracts or projectsAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California, the base pay range for this position is $85,000 to $120,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
