Engineering - Engr II, R&D CA
6 days ago
Duration: 6 Months Contract
Location: Irvine, CA
Job Description:
This Quality Engineer II will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product design, internal and external device manufacturing, and device distribution. Furthermore, this Quality Engineer will coordinate and perform complaint investigations as well as DMR/DHR changes in support of clinical inventory.
How you will make an impact:
Support areas of Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for New Product Development (NPD) programs.
Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
Coordinate and execute change control activities to support rapid innovation.
Support design and development activities (i.e., engineering study, feasibility testing, drawing review, etc.)
Participate in escalation tasks and activities, including Project Risk Assessments (PRA).
Supports or leads test method development/validation activities for Design Verification testing and manufacturing inspections for NPD programs.
Collaborate with R&D and Manufacturing organizations to facilitate the successful execution of the NPD process and launching of robust products.
Develop complex experiments and tests (including writing and executing protocols) to create, improve, and validate products and manufacturing processes by analyzing results, making recommendations, and developing reports.
Develop, update, and maintain technical content of risk management files.
Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
Assign and oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
Other incidental duties assigned by Leadership.
Ability to travel up to 10% domestically and internationally.
Required Qualifications:
Bachelor's degree in engineering or Scientific field with a minimum of (2) years of experience in either NPD, Quality Engineering, R&D, and/or Manufacturing; OR a master's degree in engineering or Scientific field with internship, senior projects, or thesis experience required.
Engineering experience within a highly regulated industry.
Preferred Qualifications:
Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation
Experience with root cause analysis or investigations for Complaints, NCRs, and/or CAPAs.
New Product Development experience from initial concept to commercialization (Class III preferred).
Experience with Risk Management and Design Control
Proven expertise in usage of MS Office Suite including MS Project
Basic understanding of statistical techniques
Strong problem-solving, organizational, analytical, and critical thinking skills
Education/Experience:
Bachelor's degree in engineering required.
2-4 years experience required.
#TB_PH
-
Engineering - Engr II, R&D CA
6 days ago
irvine, United States TalentBurst Full timeJob Title: Quality Engineer II Duration: 6 Months Contract Location: Irvine, CA Job Description: This Quality Engineer II will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product design, internal and external device manufacturing, and device distribution....
-
TalentBurst | Engineering
6 days ago
irvine, United States TalentBurst Full timeJob Title: Quality Engineer II Duration: 6 Months Contract Location: Irvine, CA Job Description: This Quality Engineer II will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product design, internal and external device manufacturing, and device distribution....
-
Electrical Test Engineer II
4 days ago
Irvine, United States R&D Partners Full timeJob DescriptionJob DescriptionDuties:Assist in the development and validation of advanced test equipment used in the manufacture of medical devices.Qualifications:BSEE or equivalent degree with 3+ years of experience.Proficient with both hardware and software design.For hardware, experience working with custom PCBAs and test instrumentation is preferred.For...
-
Senior R&D Engineering Manager.
6 months ago
Irvine, United States Medtronic Full timeCareers That Change Lives A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people. Join us as we bring the next generation of life-changing medical technology to patients worldwide. We reward you in the ways that matter...
-
Sr R&D Engineer CA
1 day ago
irvine, United States TalentBurst Full timePosition: Sr R&D Engineer, Req#: 9241-1 Location: Irvine, CA (100% Onsite) Duration: 10+ Months Contract Job Description: What does your group do? We are the THV R&D Sustaining group. We support changes and improvements to commercialized products. Does your team use any specific technology/software you want us to look out for? Microsoft Office (i.e.,...
-
Sr R&D Engineer CA
16 hours ago
irvine, United States TalentBurst Full timePosition: Sr R&D Engineer, Req#: 9241-1 Location: Irvine, CA (100% Onsite) Duration: 10+ Months Contract Job Description: What does your group do? We are the THV R&D Sustaining group. We support changes and improvements to commercialized products. Does your team use any specific technology/software you want us to look out for? Microsoft Office (i.e.,...
-
Irvine, United States TalentBurst Full timePosition: Sr R&D Engineer, Req#: 9241-1 Location: Irvine, CA (100% Onsite) Duration: 10+ Months Contract Job Description: What does your group do? We are the THV R&D Sustaining group. We support changes and improvements to commercialized products. Does your team use any specific technology/software you want us to look out for? Microsoft Office (i.e.,...
-
irvine, United States TalentBurst Full timePosition: Sr R&D Engineer, Req#: 9241-1 Location: Irvine, CA (100% Onsite) Duration: 10+ Months Contract Job Description: What does your group do? We are the THV R&D Sustaining group. We support changes and improvements to commercialized products. Does your team use any specific technology/software you want us to look out for? Microsoft Office (i.e.,...
-
Electrical Systems Validation Specialist
3 days ago
Irvine, California, United States R&D Partners Full timeJob OverviewR&D Partners is a leading national staffing firm specializing in Scientific, Clinical Research, and Engineering sectors.Our team boasts over 200 years of combined experience providing expert consulting, direct hire, and outsourcing solutions from our offices in California and Pennsylvania.Compensation PackageWe are seeking an Electrical Test...
-
R&D Intern
3 weeks ago
Irvine, United States J&J Family of Companies Full timeBiosense Webster is recruiting for a(n) R&D Engineer Intern, located in Irvine, CA. Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year. Biosense Webster, Inc. is the global...
-
R&D Manufacturing Technician
1 month ago
Irvine, United States Kelly Services Full timeJoin Our Team as an R&D Manufacturing Technician! Are you a meticulous assembler with experience in medical devices? Do you have the precision to work under a microscope and want to contribute to innovative R&D projects? If so, we'd love to have you on our team! R&D Manufacturing Technician 1st Shift: 6AM-2:30PM Pay Rate: $35 Hourly Comprehensive Benefit...
-
Medical Device R&D Project Specialist
2 weeks ago
Irvine, United States Kelly Full timeMedical Device R&D Project Specialist1st Shift: 8AM-5PMEmployment Type: Full-TimeCompensation for this role is competitive, ranging from $38 to $45 per hour, depending on experience and qualifications.Benefits: Comprehensive Benefit PackageLocation: Irvine, CAFunctions: R&D Engineering (R&D)Job Description:Kelly Services, in partnership with a global leader...
-
Medical Device R&D Project Specialist
2 weeks ago
Irvine, United States Kelly Full timeMedical Device R&D Project Specialist1st Shift: 8AM-5PMEmployment Type: Full-TimeCompensation for this role is competitive, ranging from $38 to $45 per hour, depending on experience and qualifications.Benefits: Comprehensive Benefit PackageLocation: Irvine, CAFunctions: R&D Engineering (R&D)Job Description:Kelly Services, in partnership with a global leader...
-
Senior R&D Scientist
4 weeks ago
Irvine, United States CK Group Full timeCK Group are recruiting for a Senior R&D Scientist - Atmospheric Water Harvesting, to join a small start-up team to focus on the design and scale up of systems that improve their overall performance in adsorbing/desorbing water vapor. The company is currently working on technologies in the fields of atmospheric water harvesting and CO2 capture. The ideal...
-
R&D Medical Device Assembler
2 days ago
Irvine, United States Kelly Full timeJob DescriptionImmediately Hiring R&D Medical Device Assemblers in Irvine, CAPosition Title: R&D Medical Device AssemblerPay Rate: $32-$35 Hourly1st Shift: 6AM-2:30PMComprehensive Benefit PackageLocation: Irvine, CAJob Description:R&D Medical Device Assemblers are responsible for assembling and testing medical devices used in research and development. This...
-
Quality Engineer II
4 days ago
Irvine, United States Planet Pharma Full timeQuality Engineer II Location: Irvine, CA Contract Duration: 6 months Target Pay Rate: $42/hr. with flexibilityAbout the TeamOur group focuses on New Product Development (NPD) quality and design assurance for medical devices, particularly in the area of transcatheter heart valve replacement (TAVR). This is a transformative area of healthcare, offering...
-
Engineer II-Network Operations
3 months ago
Irvine, United States TEKsystems Full timeJob DescriptionJob DescriptionOne of our top communications company looking for a Engineer II-Network Operation Onsite: Irvine, CAJob Description: JOB TITLE: Engr II-Ntwk Operations MUST HAVE SKILLS (Most Important): · Associate's degree or two or more years of work experience. · Three or more years of relevant work experience.· Ability to lift...
-
R&D Manufacturing Technician
2 days ago
Irvine, United States Kelly Full timeJob DescriptionJoin Our Team as an R&D Manufacturing Technician!Are you a meticulous assembler with experience in medical devices? Do you have the precision to work under a microscope and want to contribute to innovative R&D projects? If so, we’d love to have you on our team!R&D Manufacturing Technician1st Shift: 6AM-2:30PMPay Rate: $35 HourlyComprehensive...
-
Medical Device Packaging Engineer
1 week ago
Irvine, California, United States Pharmavise Corporation Full timeAbout the RoleWe are seeking a skilled R&D Packaging Engineer to join our team at Pharmavise Consulting Corp. in Irvine, CA. This is a 12-month contract position with a salary of $80,000 - $110,000 per year.Job SummaryThe R&D Packaging Engineer will be responsible for developing and analyzing packaging for acquisition and integration activities. The ideal...
-
R&D Product Technician
2 days ago
Irvine, United States Kelly Full timeJob DescriptionKelly Services, the industry leader in manufacturing career placement, is currently hiring R&D Product Technicians in Irvine, California. This is a fantastic opportunity to join an innovative team committed to developing life-saving medical devices.We’re seeking driven, career-focused individuals ready to take on a full-time, long-term role...