Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How you will make an impact:
- Transferring delivery system assembly manufacturing processes from an external vendor to Irvine Pilot manufacturing.
- Evaluating design concepts with respect to manufacturability by identifying, defining and mitigating risks to manufacturing/operations early in product development.
- Designing, characterizing, troubleshooting and validating delivery system manufacturing processes using Lean, Design for Manufacturing and Six Sigma methodologies.
- Developing manufacturing tooling for process improvement and mistake-proofing and driving process and equipment validations (e.g., TFIQ, IQ, OQ, PQ).
- Drafting, approving, executing, and maintaining all relevant documentation to enable seamless process and project knowledge transfer (e.g., SOPs, operator training, specifications, drawings, process sheets, validation plans, and characterization studies)
- Managing complex projects through phases of planning, execution, monitoring, and closure ensuring deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
- Collaborating with cross-functional teams (e.g., R&D, Quality, and Regulatory Affairs) on test method development, specification setting, risk management and design documentation, and strategic change management.
- Partnering with Operations and Supply Chain at the Pilot and Commercial manufacturing sites collecting VOF and ensuring successful manufacturing transfers and launch.
What you’ll need (Required):
- A Bachelor's degree in Engineering or Scientific field with 4 years of previously related industry experience OR Master’s degree in Engineering or Scientific field with 3 years of previously related industry experience Required.
What else we look for (Preferred):
- EHU/Clinical New Product Development Manufacturing experience
- Experience with updating design and risk management documentation
- Process Development (Design, Characterization and/or Validation) experience
- Strong problem-solving, organizational, analytical and critical thinking skills
- Strong project management and organizational skills
- Strong verbal/written communication and interpersonal skills
- Ability to understand basic statistical techniques
- Ability to organize and manage competing priorities in a fast-paced environment
- Ability to work well independently as well as part of a team
- Ability to interact professionally with all organizational levels
- Good leadership skills and ability to influence change
- Familiarity with Design for Manufacturability and Lean Six Sigma
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Manufacturing Engineering
- Strict attention to detail
- Proven expertise in usage of MS Office Suite including MS Project
- Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
- Knowledge of applicable FDA regulations for medical device industry
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.