Top 537 Senior product development 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
Senior AI Engineer
Flex Employee Services —Irvine, CA
- $47 - $51 an hour
- Contract
- Background check
- Computer Science
- 5 years
- Health insurance
- Dental insurance
Quick Apply
8d
Senior Backend Engineer - Mobile
Everforth —Newport Beach, CA
- Full-time
- Remote
- Computer science
- Azure
- Computer Science
Quick Apply
Senior Product Development Engineer I
Integra LifeSciences —Irvine, CA
- $81,650 - $112,700 a year
- Email
- Hybrid work
- Microsoft Excel
- Engineering
- Travel
- Disability insurance
- Health insurance
Senior Systems Engineer
Advanced Sterilization Products —Irvine, CA
- $109,700 - $183,200 a year
- Engineering
- 8 years
- Travel
Senior Product Operations Engineer, Space, Classified IT Systems
Anduril Industries —Costa Mesa, CA
- $129,000 - $171,000 a year
- Email
- System design
- Java
- Senior level
Quick Apply
Senior Spacecraft Systems Engineer
Turion Space —Irvine, CA
- $160,000 - $200,000 a year
- Full-time
- Hybrid work
- 6 years
- Analysis skills
- Manufacturing
- Paid parental leave
- Health insurance
5d
Senior Engineer, Continuous Improvement
Stryker —Irvine, CA
- $89,400 - $148,900 a year
- Full-time
- Engineering
- Mid-level
- 2 years
- Health savings account
- AD&D insurance
8d
Senior R&D Engineer - Modeling & Simulation
Medtronic —Irvine, CA
- $105,600 - $158,400 a year
- Full-time
- Office
- Master's degree
- Bachelor's degree
- Health savings account
- Employee stock purchase plan
5d
Senior Machine Learning Engineer
Capital Group Companies —Irvine, CA
- $201,683 - $322,693 a year
- Full-time
- Computer Science
- System design
- AWS
- Health insurance
- Benefits from day one
Senior Mission Systems Engineer, MBSE
Turion Space —Irvine, CA
- $125,000 - $175,000 a year
- Full-time
- 7 years
- Office
- Analysis skills
- Paid parental leave
- Health insurance
Senior Device Engineer - Lifecycle Management
Allergan Aesthetics —Irvine, CA
- $124,500 - $236,500 a year
- Full-time
- Hybrid work
- Bachelor of Science
- Windows
- 3 years
- Paid holidays
- Health insurance
Senior Reliability Engineer
Anduril Industries —Costa Mesa, CA
- $166,000 - $220,000 a year
- Email
- Bachelor of Science
- 8 years
- Analysis skills
Quick Apply
Senior Project Engineer, Manufacturing Development
Anduril Industries —Costa Mesa, CA
- $146,000 - $194,000 a year
- Email
- 3 years
- Senior level
- Leadership
Quick Apply
Senior Systems Engineer
Anduril Industries —Costa Mesa, CA
- $166,000 - $220,000 a year
- Email
- Computer science
- Computer Science
- Team management
Quick Apply
13d
Senior Staff Engineer
Stryker —Irvine, CA
- $118,000 - $196,600 a year
- Full-time
- 6 years
- Management
- Math
- Health savings account
- AD&D insurance
6d
Sr. Digital Product Development Manager (Dealer Portal)
Hyundai Capital America —Irvine, CA
- $132,000 - $204,600 a year
- Full-time
- Computer Science
- Office
- 8 years
- Paid parental leave
- Health savings account
Senior Platform Engineer
LifeMD —Huntington Beach, CA
- $150,000 - $170,000 a year
- Full-time
- Remote
- HIPAA
- Mentoring
- Senior level
- AD&D insurance
- Paid holidays
Quick Apply
5d
Senior Manufacturing Development Engineer
Anduril Industries —Costa Mesa, CA
- Email
- 3 years
- Senior level
- Leadership
Quick Apply
8d
Senior Manager, Product Management
Ford Motor Company —Long Beach, CA
- $167,200 - $316,600 a year
- Online Application
- Hybrid work
- Computer Science
- Office
- Product management
- Paid parental leave
- Paid holidays

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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

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

senior product development engineer jobs in irvine ca

Senior Systems Engineer, R&D

Senior AI Engineer

Senior Backend Engineer - Mobile

Senior Product Development Engineer I

Senior Systems Engineer

Senior Product Operations Engineer, Space, Classified IT Systems

Senior Spacecraft Systems Engineer

Senior Engineer, Continuous Improvement

Senior R&D Engineer - Modeling & Simulation

Senior Machine Learning Engineer

Senior Mission Systems Engineer, MBSE

Senior Device Engineer - Lifecycle Management

Senior Reliability Engineer

Senior Project Engineer, Manufacturing Development

Senior Systems Engineer

Senior Staff Engineer

Sr. Digital Product Development Manager (Dealer Portal)

Senior Platform Engineer

Senior Manufacturing Development Engineer

Senior Manager, Product Management

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