Engineer II, R&D
Listed on 2025-12-25
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Engineering
Biomedical Engineer, Medical Device Industry
Engineer II, R&D
Edwards Lifesciences
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Innovation starts from the heart. At Edwards, we put patients first and invest a significant portion of our revenue toward research and development to drive 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 that address significant, unmet clinical needs impacting patients’ lives worldwide.
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.
Howyou will make an impact
This is a rare opportunity to join a fast‑paced, passionate Delivery System R&D team within Edwards Lifesciences’ Transcatheter Mitral and Tricuspid Therapies group, working on transcatheter replacement therapies to address tricuspid disease. This team is deeply dedicated to transforming treatment and significantly improving patient lives around the world through valve replacement, and we need your talent.
Responsibilities- Build and evaluate products by developing complex experiments and tests (including writing and executing protocols), analyzing results, making recommendations, and developing reports, based on engineering principles.
- Evaluate manufacturing and clinical inputs, form technical recommendations, and help influence the design of future device iterations.
- Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers.
- Generate test methods, engineering models, and drawings/prototypes to characterize product and/or process specifications.
- Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback.
- Create/update sophisticated design control documents.
- Other duties assigned by Leadership.
- Bachelor's Degree in Engineering or Scientific field with 2+ years of 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.
- Mechanical Engineering degree strongly preferred.
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering design, design verification & validation.
- Catheter manufacturing processing experience.
- Medical device design & development experience.
- Experience with DV&V, OQ/PQ.
- Test method validation experience.
- Experience with statistical techniques.
- CAD experience.
- 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.
We align our overall business objectives with performance, offering 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 $85,000 to $120,000 in tool (highly experienced).
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 treat 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 requirement does not apply in locations where it is prohibited by law to impose vaccination.
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