Job Information
Edwards Lifesciences Senior R&D Engineer, Valve Testing in Irvine, California
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
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.
How you’ll make an impact
Develop new test methods and models to evaluate design intent and performance of next generation mitral or tricuspid valves
Create, test, and/or improve products by developing 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 models and drawings/prototypes
Test class III implantable medical devices in accordance with the specifications, medical guidance, and regulatory safety standards.
Support and execute implant-testing operations as a member of the valve product development team.
Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work; train, coach, and guide lower-level employees on routine procedures
Other duties assigned by Leadership
What you’ll need
A bachelor’s degree in biomedical engineering, mechanical Engineering or related/equivalent engineering/scientific discipline with 4 years of experience required. Advanced degree is a plus
Minimum of 4 years of relevant experience (BS + 4 years or MS + 3 years or PhD + 0 years) with preferable experience with new product development of Class III medical device implants
What else we look for
Knowledge and experience of relevant FDA guidance and ISO standards such as ISO5840 is highly desired.
Must be a highly motivated self-starter and able to achieve the quality results with minimal direction.
Must be proactive and creative in solving technical problems with limited amount of data/information.
Requires a high-energy individual with excellent team-player attitude and well-developed negotiation skills.
Excellent verbal and written communication skills, project-management skills, detail orientation and analytical/problem solving skills are a must.
Proven expertise in usage of MS Office Suite; CAD experience preferred
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Basic understanding of statistical techniques
Comfortable working in a laboratory environment and with animal tissue, experience with in vitro experimental testing
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 $103,000 to $146,000 (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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