Principal Engineer, Manufacturing

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

The Principal Engineering role is a great opportunity to support the IHFM manufacturing team as we begin to set up operations in Irvine. In this role you will begin by setting up the distribution and servicing operations for one of our most recent acquisitions. Upon successful setup in Irvine, you will join the team responsible for transferring our first sensor manufacturing line to Irvine.  You will also support the IHFM team by managing engineering activities such as new product introductions, stabilization activities, and commercial manufacturing.

How you’ll make an impact:

• Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes (IQ/OQ/PQ/SWV/TMV); analyze results, make recommendations, and develop reports.

• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.

• Lead and establish complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)

• Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).

• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards.

• Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.

• Perform other duties and responsibilities as assigned.

What we look for:

• Bachelor’s degree in Engineering or Scientific with a minimum of 6 years of manufacturing engineering experience in a highly regulated industry.

• Onsite required.

• Must have ability to travel up to 10%.

What else we look for:

• Class II and Class III medical device manufacturing experience.

• Advance degree.

• Lean Six Sigma certification.

• Experience with Windchill PTC.

• Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering as well as the production development process (PDP).

• Proven expertise in usage of MS Office Suite.

• Effective communication and project management.

• Strong analytical, problem solving, and technical writing skills.

• Ability to work well independently based on minimal guidance.

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 $121,000 to $171,000 (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.