Principal Engineer, Design Assurance

Innovation starts from the heart. Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.

This engineer will collaborate with a cross-functional design team to develop novel cardiovascular device/therapy, providing quality leadership and vision throughout the initial product development cycle up to commercialization, while ensuring compliance to applicable internal and external requirements. In this position, the engineer will work closely with R&D to define strategy, as well as refine and finalize the design per the NPD process.  In addition, the engineer will work with the Operations team to help facilitate successful transfer/launching of robust products. This position provides an opportunity to work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.

How You'll Make an Impact:

• Collaborate with the R&D and Operations teams in the areas of Design Engineering, Risk Management, Design Controls, Design Verification, Statistical Techniques, Test Method Development, Process Development, Quality Assurance, and Regulatory Compliance.

• Lead Risk Management process for project in compliance to appropriate external standards and corporate policies, to ensure critical to quality features are identified and addressed appropriately.

• Responsible for creating and maintaining risk management documentation such as risk management worksheet, FMEAs in alignment with ISO:14971

• Provide integral technical input for the development of project plans, project timelines and strategy to support premarket approval of products.

• Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities.

• Strong leadership and collaboration with other leaders in project and across the organization

• Mentor engineers in understanding of quality systems and strategies within new product development.

• Support root cause investigations/product evaluations for product failures encountered during clinical use using engineering methods (Six Sigma, DMAIC, etc.)

• Support resolution of manufacturing and compliance issues (i.e. CAPA, non-conformances, audit observations, etc.) utilizing problem solving tools.

• Support Quality Engineering activities to improve customer satisfaction and successful achievement of company quality objectives.

• Responsible for ensuring compliance with all National/Federal, local, and company regulations, policies and procedures.

• Train, coach, and guide lower-level employees on more complex procedures

• Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work. 

What You'll Need (Required):

• Bachelor’s degree in engineering and minimum of 6 years of experience within the medical device industry, or a combination of medical device and other related regulated environment experience
  or

• Master's degree in in engineering and minimum of 5 years of experience within the medical device industry, or a combination of medical device and other related regulated environment experience

What Else We Look For (Preferred):

• In-depth knowledge of Design Control, Risk Management, and related standards, as applicable for medical devices.

• Knowledge of Quality Engineering and Six Sigma concepts with ability to apply to work product

• Strong technical and analytical engineering skills. Able to understand drawings and device design at a practical level.

• Excellent verbal and written communication skills. Able to communicate clearly and concisely yet thoroughly.

• Strong leadership skills and ability to influence change

• Ability to handle multiple tasks simultaneously.

• Must be accurate in handling detailed information/data.

• Experience in early human use NPD strongly preferred.

• Experience in Design for Manufacturing (DFM) preferred.

• Certified Six Sigma Black belt / CQE preferred.

• Experience with electronic devices, data transmission/acquisition a plus.

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 $118,000 to $167,000 (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.