Jobs / Edw***
Systems Engineer II, R&D
Edw*** · Irvine, CA, United States
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Irvine, CA, United States87,000-123,000 USD/yearlyOnsite
Remuneration
87,000-123,000 USD/yearly
Location
Irvine, CA, United States
Visa sponsorship
Sponsors visa
Job summary
Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease.
Benefits
Programs to address the diverse individual needs of our employees and their famiFor California, the base pay range for this position is $87,000 - $123,000 (highThe pay for the successful candidate will depend on various factors (e.g.,
Qualifications
- hazard analyses, DFMEAs, UFMEAs) under guidance
- Perform design change impact assessments evaluating effects on risk,
- and verification/validation activities
- Ensure adherence to applicable standards, regulatory
- and internal procedures throughout development
- Conduct user research and usability evaluations to inform safe and effective design improvements
- Contribute to maintaining the Design History File (DHF), ensuring documentation is complete, accurate, and traceable
- Support system-level problem-solving and contribute to design and development strategies aligned with project objectives
- Coordinate and provide guidance to technicians on test execution and routine R&D support activities
- Evaluate technical inputs and contribute to design recommendations for components and subsystems
- Perform additional
- Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of
Responsibilities
- As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest
- as assigned
- What you'll need (Required):
- What else we look for (Preferred):
- Prior experience performing testing to support V&V and risk management activities for medical device development
- Prior experience working within Design Controls and DHF ownership
- Experience with medical devices and FDA quality practices and standards, including ISO 13485
- Prior experience processing, parsing, and analyzing data, including script development for automation and statistical analysis methods using Excel and Minitab
- Demonstrated ability to work independently with minimal supervision
- Strong written and verbal communication
Skills
CommunicationExcelPatient Care
Degrees
AssociateBachelorDegreeMaster
Industry
AutomotiveEducationHealthcareManufacturing
Company size
Smb
Contract length
2 years