Engineer II, R&D

4 days ago

Irvine, United States Edwards Lifesciences Full time

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: This is an exciting opportunity to join the Edwards Surgical R&D engineering organization. The Engineer II position will have high collaboration and work with different functions including R&D, quality, commercial manufacturing, global supply chain (GSC), regulatory and marketing. This engineer will learn and apply knowledge of technical principles and Edwards systems/procedures to support product life cycle management by optimizing product design, contributing to commercialization of new product, assisting the development of optimized manufacturing processes, and supporting regulatory submissions and marketing activities. The ideal candidate is a self- starter and has strong communication and collaboration skills, who has a strong desire to learn and is a quicker learner. Key responsibilities also include: Create, test, and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles Generate work instructions, test methods, engineering drawings/prototypes, etc. to establish/characterize product and/or process specifications Create/update portions of design control documents including requirement specs and risk documents Partner with technical engineers on new products in the PDP process and its main interface between R&D, quality, pilot, supplier development, and commercial manufacturing. Provide relevant inputs and feedback to the development team on device design and manufacturability. As required, generate data or information through DOE, characterization studies, stack-up analyses, etc. Assign R&D support tasks; gives instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers Evaluate input and form a technical recommendation including designing parts, components and subsystems Under guidance, develop and execute engineering project plans Train, coach, and guide lower-level employees on routine procedures Other duties assigned by Leadership What you'll need (Required): Bachelor's Degree in Engineering or Scientific field with 2 years' experience -OR- Master's Degree or equivalent in Engineering or Scientific field with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education What else we look for (Preferred): Product development experience, with a working knowledge of relevant CAD design skills and proficient in Solidworks, Creo, etc. Medical device design and manufacturing experience in heart valves, stents, tissue, catheters, delivery systems and/or interventional access devices. Understanding medical device quality system, design control, and regulatory requirements Solid documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills Solid understanding and knowledge of principles, theories, and concepts relevant to engineering and statistical analysis techniques Previous experience working with lab/industrial equipment required (if applicable) Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering, including GD&T, tolerance stack-up analysis, CTQ/CCP. Understanding root cause investigations with CAPA, FMEA and PRAs. Solid problem-solving, organizational, analytical and critical thinking skills Solid understanding of processes and equipment used in assigned work Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including the ability to manage vendors and project stakeholders Ability to build productive internal/external working relationships Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Aligning 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 $83,000 to $117,000 (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 Requirement Edwards 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.

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