Principal Engineer, R&D

Principal Engineer, R D Edwards Lifesciences - 3.9 Irvine, CA Job Details Full-time $87,000 - $123,000 a year 2 hours ago Qualifications Developing medical devices Product design project leadership Managing medical device teams New product introduction engineering projects Product development project management Medical device testing Technical documentation Engineering Process improvement Master's degree Team development Collaboration with product development teams Research project technical leadership Analysis skills Policy & process development Bachelor's degree in engineering Managing engineering teams Decision making Mentoring Design engineering Quality engineering Collaboration with manufacturing teams Design for manufacturability (DFM) Design controls Senior level 4 years Design of individual components Research & development Project risk management Communication skills Full Job Description 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 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. Edwards Lifesciences is looking for a Principal Engineer to join the THV Access R D team to work on and drive a next-generation expandable sheath in support of our THV Replacement platforms. This role will be responsible for the technical design and development throughout the full development cycle from product concept through commercialization; working with a cross-functional team to achieve both clinical and commercial milestones. How you'll make an impact: Drive the technical development of the next-generation Access device, including Design for Manufacturing considerations, through all phase of the Design Control process; be the Subject Matter Expert on the device Guide the development of product and component specifications Develop and execute a strategy for Design Verification testing of the device, appropriate to the design control pathway, including biocompatibility activities Develops technical solutions to complex problems which require the regular use of creativity Uses best practices and knowledge of internal or external business issues to improve products/services or processes Ability to resolve complex problems or problems where precedent may not exist Help execute a long-term strategy for deploying new design solutions within the Access platform; partner with process development team and commercial manufacturing sites to implement new designs Guide and mentor the technical team to solve complex technical issues Promote knowledge sharing within the team and across teams/functions What you'll need (Required): Bachelor's degree in Engineering or Scientific field with 6 years of experience , or a Master's degree with 5 years of experience What else we look for (Preferred): A minimum of 4 years of experience in product and/or process development Proven track record in product/process development; capable of articulating a strategy for progressing towards a loosely defined development goal Ability to foresee and manage risks within current projects and/or technology Great problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making Great documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives Ability to influence cross-functional partners, business units, and/or sites Ability to represent the organization in providing solutions to difficult technical issues associated with specific projects 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 (CA), the base pay range for this position is $87,000 to $123,000 (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. E dwards 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.