Engineer II, Clinical Development

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. 

 How you’ll make an impact:

• The Engineer II serves as a technical contributor supporting the design, development, and optimization of innovative medical technologies. This role collaborates cross-functionally with R&D, clinical, and manufacturing teams to translate engineering concepts into practical solutions, support product development initiatives, and drive continuous improvement. The Engineer II applies engineering principles and analytical thinking to solve complex problems, enhance product performance, and contribute to the advancement of safe and effective therapies
• Applies engineering expertise and judgment to support Clinical Development activities and business outcomes.
• Create, test, and/or improve clinical procedures by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering and clinical principles
• Generate moderately complex clinical design inputs, test methods, engineering drawings/prototypes, etc. to establish/characterize product and/or process specifications, as well as design down-selection inputs
• Assign intern/technician Clinical Development support tasks; gives instruction to intern/technician on conducting tests, benchtop set-ups; train technicians and provide feedback; and coordinate intern/technician work
• Contributes to design inputs with clinical findings and analysis for upcoming and sustaining programs, including design control documents such as requirement specifications and risk documents with consultation from senior team members
• Train, coach, and guide lower level employees on routine procedures
• Relationship management with outside vendors, KOLs from industry and clinic for driving project objectives

What you’ll need (Required):

• Bachelor's Degree in Engineering or Scientific field with 2 years experience  Required or
• Master's Degree or equivalent in Engineering or Scientific field internship, senior projects or thesis in Engineering or Scientific field Preferred
• Position sits on site in Irvine, Ca full time with travel up to 25% nationwide

 What else we look for (Preferred):

• Good computer skills 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
• Good understanding of statistical techniques including experimental test method development in scientific research or related technical work
• Basic understanding of clinical imaging preferred
• Previous experience working with lab/industrial equipment required'
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering, clinical practices for TMTT therapeutic devices, and imaging modalities
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Good knowledge and continuous education/advancement on understanding of cardiovascular anatomy, pathology, and physiology as well as general hospital environment and equipment
• Proficiency in imaging analysis and technology platforms preferred
• Ability to develop solutions to a variety of problems of moderate scope and complexity
• Ability to contribute to process, procedure, or test method improvements related to clinical development activities
• 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, as well as global internal and external partners
• Ability to build productive internal/external working relationships, including external Key Opinion Leader or physicians

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.  

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.