For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology. With this impactful vision in mind, we are now embarking on becoming an independent business from Edwards, a process that we currently expect to be completed by January... more details
For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology.
With this impactful vision in mind, we are now embarking on becoming an independent business from Edwards, a process that we currently expect to be completed by January 2025.
As Critical Care transitions to an independent company, we will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with strong investment in our future pipeline, and strong sales growth and profitability. We are well-positioned to build upon our category leadership as we continue to launch new solutions powered by A.I. to clinicians, and expand into new care settings.
So, if you're a dynamic and passionate person who is eager to contribute to an innovative, industry-leading advanced monitoring company we invite you to explore our career opportunities. Those who choose to join us will be part of a ‘once-in-a-lifetime’ journey to improve the quality of care and outcomes for millions of patients around the world.
Appendix:
For further detail on the spin-off of Critical Care from Edwards Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99:
https://ir.edwards.com/events-presentations/event-details/2023/Edwards-Lifesciences-2023-Investor-Confe rence-2023-bK2BbXaBha/default.aspx
How You'll Make an Impact:
Working with multiple internal project teams to coordinate and execute supplier development deliverables at external component suppliers for Edwards Critical Care products.
Being the primary contact for designated suppliers and ensuring that all phases of product/process development conform to required quality standards while meeting program timing/key milestones for production launch.
Creating inspection methods to evaluate supplier performance against the design specifications and to support supplier on-site acceptance testing. Minor fixture development, Keyence programming, early capability studies.
Supporting R&D teams to provide DFM assessments, ensuring designs are being looked at from the lens of process stability and inspection.
Resolving supplier component-related problems, including yield and failure analyses.
Assisting suppliers to ensure that selection, development, and validation of manufacturing processes, equipment, and tooling are performed to the meet Edwards’ procedures, ISO 13485 and FDA requirements.
Developing and writing technical reports/summaries, and validation/verification documents. Properly documenting activities in accordance with best engineering practices, company procedures, and regulatory requirements.
Providing ongoing quality monitoring and interface with external suppliers on manufacturing line issues to ensure highest quality product is maintained.
Training and educating suppliers on industry best practices and requirements to develop and improve their ability to meet medical device manufacturing industry expectations.
Facilitating and managing component level qualification testing that leads to the approval of components for use in Critical Care products.
Conducting supplier assessments to drive selection of robust suppliers and development plans for those suppliers needing performance improvement.
Perform other duties and responsibilities as assigned.
What You’ll Need (Required):
Bachelor's degree in engineering; mechanical, biomedical, or manufacturing engineering is preferred and 2-4 years of engineering experience in medical device manufacturing. An advanced degree may offset some required experience.
What Else We Look For (Preferred):
Good engineering judgement and demonstrated analytical, quality problem analysis, and resolution skills.
Strategic planning and critical thinking skills to be able to plan, organize, and manage multiple priorities.
Basic understanding and with experience in performing medical device manufacturing process validations (IQ/OQ/PQ).
Basic understanding of inspection methods (experience with Keyence highly preferred).
Basic equipment knowledge and process experience for components used in Edwards Critical Care. This includes but is not limited to: sheet metal processes, converted materials, thermoforming, PCBA / SMT, injection molding, cable manufacturing, 3D printing, and high volume product assembly.
Basic ability to read and interpret engineering drawings for the purpose of understanding product design and identifying to critical to quality features (GD&T training highly preferred).
Basic understanding of manufacturing-related statistical techniques (Gage R&R, SPC, Process Capability Analysis, ANOVA, etc.).
Ability to work well both independently and as a member of a team is essential.
Excellent documentation and communication skills and interpersonal relationship skills.
Domestic and international travel is likely required; expected 10% travel.
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 $83,000 to $117,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.