Top 151 Medical device validation 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
Technical Operations Manager – Immunoassay Manufacturing
Biomerica —Irvine, CA
- $90,000 - $120,000 a year
- Full-time
- 7 years
- Master's degree
- Assembly
- Health insurance
- Dental insurance
Quick Apply
4d
Senior Engineer, R&D Sustainment
Edwards Lifesciences —Irvine, CA
- $108,000 - $153,000 a year
- Full-time
- Engineering
- 3 years
- Analysis skills
9d
Director Engineering, New Product Development
Edwards Lifesciences —Irvine, CA
- $159,000 - $226,000 a year
- Full-time
- Surgery
- 5 years
- Engineering
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
Hardware Test Engineer (Medical Device)
Canon Recruiting Group —Irvine, CA
- $120,000 - $150,000 a year
- Full-time
- Mid-level
- 3 years
- Fair chance
- 401(k)
Quick Apply
9d
Manufacturing Tech II
TalentBurst, Inc. —San Clemente, CA
- $20.25 an hour
- Contract
- High school diploma or GED
- Entry level
- Under 1 year
- Health insurance
- Dental insurance
Quick Apply
12d
Facilities & Maintenance Manager
Lubrizol —Corona, CA
- $138,000 - $169,000 a year
- Full-time
- CPR Certification
- 5 years
- First Aid Certification
- Health savings account
- Paid holidays
Senior Quality Engineer
Lubrizol —Corona, CA
- $135,000 - $145,000 a year
- Full-time
- Engineering
- Analysis skills
- Senior level
- Health savings account
- Paid holidays
Head of Operations and Manufacturing - Medical Device (Hybrid or Remote)
Canon Recruiting Group —Irvine, CA
- $160,000 - $210,000 a year
- Full-time
- Remote
- Engineering
- Travel
- Fair chance
- Health insurance
- Dental insurance
Quick Apply
Consultant - Product Quality & Safety - Life Sciences & Healthcare
Deloitte —Costa Mesa, CA
- $88,700 - $170,900 a year
- Full-time
- Up to 50% travel
- Bachelor's degree
- Product management
Senior Facilities Engineer
Kelly Services —Yorba Linda, CA
- $45 - $55 an hour
- Full-time
- 5 years
- Bachelor of Science
- Engineering
- Paid holidays
- Disability insurance
Quick Apply
10d
Research Associate
SigmaGraft Inc. —Fullerton, CA
- From $24 an hour
- Full-time
- Continuous improvement
- In-person
- Associate's degree
- Health insurance
- Paid time off
Quick Apply
4d
Clinical Validation Engineer
Diality —Irvine, CA
- $95,000 - $112,000 a year
- Full-time
- Master's degree
- Bachelor's degree
- Travel
Quick Apply
QA Associate
PSC Biotech —Irvine, CA
- $85,000 - $115,000 a year
- Engineering
- 3 years
- Continuous improvement
4d
Packaging Engineer
AbbVie —Irvine, CA
- $65,500 - $125,500 a year
- Full-time
- Hybrid work
- Engineering
- Math
- Mentoring
- Paid holidays
- Health insurance
10d
Systems Engineer II, R&D
Edwards Lifesciences —Irvine, CA
- $87,000 - $123,000 a year
- Full-time
- Engineering
- Mid-level
- Analysis skills
10d
Quality Engineer I
Medtronic —Irvine, CA
- $66,400 - $99,600 a year
- Full-time
- Inventory control
- Office
- Analysis skills
- Health savings account
- Employee stock purchase plan
3d
New Product Development Engineer
Katalyst Healthcares & Life Sciences —Irvine, CA
- Contract
- 5 years
- Analysis skills
- Senior level
Quick Apply
Validation Engineer
Cryoport Systems —Irvine, CA
- Up to $120,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- Analysis skills
- Health insurance
- 401(k) matching

I want to receive the latest job alert for medical device validation in irvine, ca

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

medical device validation jobs near irvine, ca

Research Associate jobs in Fullerton, CA

Senior R&D Engineer jobs in Irvine, CA

Quality Engineer jobs in Irvine, CA

Validation Engineer jobs in Irvine, CA

Senior Product Development Engineer jobs in Irvine, CA

Hardware Engineer jobs in Irvine, CA

Quality Assurance Associate jobs in Irvine, CA

Senior System Engineer jobs in Irvine, CA

Director Of Engineering jobs in Irvine, CA

Packaging Engineer jobs in Irvine, CA

Facilities Manager jobs in Corona, CA

Life Science Consultant jobs in Costa Mesa, CA

Clinical Research Coordinator jobs in Richmond, VA

Psychology Research jobs in Charlotte, NC

Research Associate jobs in Hollywood, FL

Research Associate jobs in College Park, MD

Research Associate jobs in Redwood City, CA

Per Diem Research Assistant jobs in Boston, MA

Research Associate jobs in Riverside, CA

Clinical Research Coordinator jobs in San Jose, CA

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

medical device validation jobs in irvine, ca

Senior Systems Engineer, R&D

Technical Operations Manager – Immunoassay Manufacturing

Senior Engineer, R&D Sustainment

Director Engineering, New Product Development

Director of Engineering

Hardware Test Engineer (Medical Device)

Manufacturing Tech II

Facilities & Maintenance Manager

Senior Quality Engineer

Head of Operations and Manufacturing - Medical Device (Hybrid or Remote)

Consultant - Product Quality & Safety - Life Sciences & Healthcare

Senior Facilities Engineer

Research Associate

Clinical Validation Engineer

QA Associate

Packaging Engineer

Systems Engineer II, R&D

Quality Engineer I

New Product Development Engineer

Validation Engineer

I want to receive the latest job alert for medical device validation in irvine, ca

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected