Top 511 Regulatory compliance 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
Principal Facilities Engineer
Brooksource —Irvine, CA
- $70 - $85 an hour
- Contract
- Spanish
- 7 years
- Construction site
- Health savings account
- Paid holidays
Quick Apply
Embedded Software Engineer with HIL
Laiba Techonology LLC —Irvine, CA
- $120,000 - $130,000 a year
- Full-time
- Mid-level
- In-person
- Communication skills
- Health insurance
- Dental insurance
Quick Apply
22h
Staff Electrical Engineer
Confidential —Irvine, CA
- $150,000 - $180,000 a year
- Full-time
- Bachelor of Science
- Continuous improvement
- Mentoring
Quick Apply
8d
Senior Manager, FAA Regulatory Compliance Engineer
Virgin Galactic —Tustin, CA
- $122,364 - $186,636 a year
- Full-time
- 5 years
- Engineering
- Maintenance
9d
Senior Regulatory Engineer
Rivian and Volkswagen Group Technologies —Irvine, CA
- $135,100 - $168,900 a year
- Email
- Hybrid work
- Computer Science
- 5 years
- Senior level
Senior Compliance Engineer
Anduril Industries —Costa Mesa, CA
- $146,000 - $194,000 a year
- Email
- Computer science
- Computer Science
- System design
Quick Apply
EHS Engineer
Hyper Solutions Inc —Anaheim, CA
- $100,000 - $120,000 a year
- Mid-level
- 3 years
- Continuous improvement
Senior Engineer I-Quality (Calibration and Metrology)
Microchip Technology —Garden Grove, CA
- $70,304 - $205,000 a year
- Full-time
- Engineering
- Travel
- Manufacturing
- Employee stock purchase plan
- Health insurance
6d
Supplier Quality Engineer II
Medtronic —Irvine, CA
- $80,000 - $120,000 a year
- Full-time
- Mid-level
- Office
- Master's degree
- Health savings account
- Employee stock purchase plan
Lead EHS & Facilities Engineer
Mach Industries —Huntington Beach, CA
- $150,000 - $170,000 a year
- Full-time
- Team management
- US work authorization
- Recruiting
- Retirement plan
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
Cybersecurity Quality Engineer
Masimo —Irvine, CA
- $85,000 - $105,000 a year
- Full-time
- Computer Science
- Schematics
- English
- Paid parental leave
- AD&D insurance
Information Security Engineer
Financial Partners Credit Union —Costa Mesa, CA
- $115,700 - $162,200 a year
- Full-time
- Computer science
- Computer Science
- 5 years
Quick Apply
Quality System Engineer II
BALT Group —Irvine, CA
- $90,000 - $100,000 a year
- Microsoft Excel
- Mid-level
- Office
Quick Apply
Staff Software Safety Engineer
Anduril Industries —Costa Mesa, CA
- $191,000 - $253,000 a year
- Email
- Computer science
- Computer Science
- 5 years
Quick Apply
Identity Governance & Administration (IGA) Engineer (Saviynt)
MKS Inc. —Irvine, CA
- $88,000 - $147,000 a year
- Full-time
- Analysis skills
- Continuous improvement
- US work authorization
- Paid holidays
- Disability insurance
Quick Apply
Product Design & Development Engineer
Innova Electronics Corp —Irvine, CA
- $85,000 - $90,000 a year
- Full-time
- Background check
- 5 years
- English
- Health insurance
- Dental insurance
Quick Apply
Senior Quality Engineer
Calnetix Technologies, LLC —Cypress, CA
- From $130,000 a year
- Full-time
- Engineering
- 8 years
- Analysis skills
Quick Apply
Field Service Engineer
Design Catapult Mfg, Inc. —Fountain Valley, CA
- $30 - $35 an hour
- Full-time
- Engineering
- Mid-level
- Driver's License
- Paid holidays
- Health insurance
Quick Apply

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regulatory compliance engineer jobs near irvine ca

Senior Systems Engineer, R&D

Edwards Lifesciences -
Irvine, CA

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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

regulatory compliance engineer jobs in irvine ca

Senior Systems Engineer, R&D

Principal Facilities Engineer

Embedded Software Engineer with HIL

Staff Electrical Engineer

Senior Manager, FAA Regulatory Compliance Engineer

Senior Regulatory Engineer

Senior Compliance Engineer

EHS Engineer

Senior Engineer I-Quality (Calibration and Metrology)

Supplier Quality Engineer II

Lead EHS & Facilities Engineer

Quality Engineer I - Fluid Systems Division

Cybersecurity Quality Engineer

Information Security Engineer

Quality System Engineer II

Staff Software Safety Engineer

Identity Governance & Administration (IGA) Engineer (Saviynt)

Product Design & Development Engineer

Senior Quality Engineer

Field Service Engineer

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