Top 544 Systems engineer Jobs in Irvine, Ca

Senior Systems Engineer, R&D
Edwards Lifesciences —Irvine, CA
- $108,000 - $153,000 a year
- Full-time
- Engineering
- 3 years
- Doctor of Philosophy
10d
Director of Engineering
NeurOptics —Irvine, CA
- $175,000 - $250,000 a year
- Full-time
- Computer Science
- Engineering
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
Radar Systems Engineer
RedBalloon LLC —Brea, CA
- $170,000 - $210,000 a year
- Full-time
- Bachelor of Science
- System design
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
Fabulous Junior IT Solutions Engineer
Squeeze Technology, Inc. —Lake Forest, CA
- $55,000 - $65,000 a year
- Full-time
- Computer Science
- Analysis skills
- In-person
- Health savings account
- Health insurance
Quick Apply
Propulsion Systems Engineer
eTeam Inc —Tustin, CA
- $48 - $60 an hour
- Contract
- Mid-level
- Analysis skills
- Continuous improvement
Quick Apply
Systems Engineer
Arkham Technology Ltd. —Irvine, CA
- $85,000 - $180,000 a year
- Full-time
- Microsoft Excel
- Computer Science
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
5d
Systems Engineer
Lendistry —Tustin, CA
- $115,800 - $130,200 a year
- Full-time
- Computer Science
- Bachelor of Science
- System design
- Health savings account
- Paid holidays
Quick Apply
9d
Spacecraft Systems Engineer
Turion Space —Irvine, CA
- $120,000 - $160,000 a year
- Full-time
- Hybrid work
- Mid-level
- 3 years
- Analysis skills
- Paid parental leave
- Health insurance
Open Architecture Systems Engineer, C2
Anduril Industries —Costa Mesa, CA
- $146,000 - $194,000 a year
- Email
- Computer Science
- Bachelor of Science
- Mid-level
Quick Apply
11d
Systems Engineer, EW
Anduril Industries —Costa Mesa, CA
- $166,000 - $220,000 a year
- Email
- Analysis skills
- Senior level
- Leadership
- Commuter assistance
- Paid parental leave
Quick Apply
Systems Engineer II, R&D
Edwards Lifesciences —Irvine, CA
- $87,000 - $123,000 a year
- Full-time
- Engineering
- Mid-level
- Analysis skills
10d
Business Systems Analyst (Limited-Term)
County of Orange —Santa Ana, CA
- $94,531 - $137,069 a year
- Online Application
- Hybrid work
- Computer science
- Azure
- Computer Science
- AD&D insurance
- Paid holidays
5d
Senior Systems Engineer
Advanced Sterilization Products —Irvine, CA
- $109,700 - $183,200 a year
- Engineering
- 8 years
- Travel
Systems Engineer
Ascent Aerospace —Santa Ana, CA
- $55 - $72 an hour
- Weekends as needed
- Microsoft Excel
- Ability to walk for extended periods
- Bachelor of Science
- AD&D insurance
- Disability insurance
Quick Apply
Endpoint Engineer - Factory Systems
Anduril Industries —Costa Mesa, CA
- $129,000 - $171,000 a year
- Email
- System design
- Windows
- 3 years
Quick Apply
Systems Integration Engineer
DZYNE Technologies LLC. —Irvine, CA
- $120,000 - $160,000 a year
- Engineering
- Mid-level
- Office
- Paid holidays
- Health insurance
IT Systems Engineer
Anduril Industries —Costa Mesa, CA
- $130,000 - $171,000 a year
- Email
- System design
- Mid-level
- 3 years
Quick Apply
Spacecraft Systems Engineer
Terran Orbital Corporation —Irvine, CA
- $100,000 - $140,000 a year
- Full-time
- Bachelor of Science
- Office
- Bachelor's degree
- Paid parental leave
- Health insurance
Quick Apply
Quality Engineer I - Fluid Systems Division
Parker Hannifin Corporation —Irvine, CA
- $83,250 - $132,150 a year
- Full-time
- Bachelor of Science
- Mid-level
- Math
- Paid parental leave
- Paid holidays
Sr. Systems Engineer
Skyward IT —Laguna Niguel, CA
- $110,000 - $135,000 a year
- Full-time
- Background check
- Google Workspace
- Azure
- Paid holidays
- Health insurance
Quick Apply

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Senior Systems Engineer, R&D

Edwards Lifesciences -
Irvine, CA

Apply Now

Job Details

Full-time
$108,000 - $153,000 a year
10 days ago

Qualifications

Developing medical devices
Medical device validation
Quality control product testing
Medical device testing
ISO standards
Quality risk management
Quality control documentation
Compliance documentation
Design controls
Biomedical regulatory compliance

Full Job Description

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. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.

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.

How you will make an impact:

As a Systems Engineer, this individual will be a member of the Research & Development team, responsible for new product design and development, risk management, and product performance improvements for the hardware components of the Cordella platform. This is a collaborative position in which the Systems Engineer will work closely with other hardware and software engineers, quality, regulatory, manufacturing, and other individuals throughout the company.

Lead development and execution of engineering project plans, including designing and conducting complex experiments (including writing and executing protocols), analyzing results, and delivering reports based on engineering principles
Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications
Create/update more complex design control documents including requirement specs, and risk documents (Hazard Analysis, Design FMEAs, and Use FMEAs)
Lead design change impact assessments, ensuring risks, requirements, and validations are appropriately addressed
Ensure compliance with applicable standards and regulatory requirements throughout the product lifecycle
Conduct user research and usability evaluations to support safe, effective design decisions
Maintain a complete, organized Design History File (DHF) to support traceability and audit readiness
Drive system-level strategies and solutions to effectively navigate design and development processes, ensuring alignment with technical, regulatory, and business objectives
Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
Evaluate input and form a technical recommendation including designing parts, components and subsystems
Train, coach, and guide lower-level employees on routine procedures
Other duties assigned

What you'll need (Required):

Bachelor's Degree in Engineering or Scientific field with 4 years of experience -OR- Master's Degree or equivalent in Engineering or Scientific field with 3 years of experience -OR- Ph.D. or equivalent in Engineering or Scientific field
Experience with medical devices and FDA quality practices and standards, including ISO 13485
Prior experience performing testing to support V&V and risk management activities
Prior experience working within Design Controls and DHF ownership
Relocation is not provided for this role. Only candidates within a 50-mile radius of Irvine, CA will be considered.

What else we look for (Preferred):

Experience in medical devices with both hardware and data and/or software is preferred
Experience with FDA submissions for product approvals
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 with the ability to clearly document technical rationale and present findings to cross-functional stakeholders.
Demonstrated organizational, interpersonal, and critical thinking skills
Strict attention to detail and commitment to high quality documentation
Ability to interact professionally with all organizational levels
Ability to work effectively in a team-oriented, fast-paced, regulated environment while managing multiple priorities
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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 $108,000 to $153,000 (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.

E dwards 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.

Apply Now

Refine Your Search

systems engineer jobs in irvine, ca

Senior Systems Engineer, R&D

Director of Engineering

Radar Systems Engineer

Fabulous Junior IT Solutions Engineer

Propulsion Systems Engineer

Systems Engineer

Systems Engineer

Spacecraft Systems Engineer

Open Architecture Systems Engineer, C2

Systems Engineer, EW

Systems Engineer II, R&D

Business Systems Analyst (Limited-Term)

Senior Systems Engineer

Systems Engineer

Endpoint Engineer - Factory Systems

Systems Integration Engineer

IT Systems Engineer

Spacecraft Systems Engineer

Quality Engineer I - Fluid Systems Division

Sr. Systems Engineer

I want to receive the latest job alert for systems engineer in irvine, ca

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