Design Engineer

3B Staffing LLC

Irvine, CA

Responsibilities

Develop quality assurance documentation for new product development and regulatory submissions.
Maintain quality system for design control by identifying and correcting deficiencies.
Engage in design, development, manufacturing, and risk management activities.
Participate in design reviews, identifying risks and tracking mitigation measures.
Define design verification and validation test requirements and complete reports with statistical validity.
Support Advanced Operations in developing manufacturing processes for new products.
Utilize statistical analysis and problem-solving techniques to determine product acceptance limits and resolve quality issues.
Develop, review, and approve inspection plans, routers, and product drawings.
Support product design transfers to manufacturing facilities.
Evaluate predicate products for relevant quality issues impacting new product development.
Analyze and define critical quality attributes through risk analysis techniques.
Collect initial market feedback and address early concerns.
Lead risk management activities by developing risk management plans and conducting risk reviews.

Essential Skills

Experience with medical device product development lifecycle, including risk management and design/process verification and validation.
Applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
Ability to read and interpret CAD drawings.
Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).
Thorough knowledge of US and International Medical Device Regulations.
Strong project management skills and ability to manage multiple tasks.
Advocacy for product excellence and quality.
Ability to work cross-functionally with departments such as Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
Strong interpersonal, written, oral communication, and negotiation skills.
Critical and 'outside the box' thinking.
Problem-solving and analytical skills.
Ability to manage and complete projects in a matrix organization.
Ability to work independently.
Experience in compliance risk situations.
Computer literacy, including proficiency with Mini-Tab or similar analysis programs.

Additional Skills & Qualifications

Strong knowledge of Quality Concepts such as CAPA, Audits, and Statistics.
Demonstrated ability to effectively manage multiple tasks simultaneously.
Demonstrated ability to advocate for product excellence and quality.
Strong interpersonal skills and ability to work cross-functionally.

Apply

Vacancy posted 2 days ago

Similar jobs that could be interesting for youBased on the Design Engineer in Irvine, CA vacancy

Sr. ASIC Design Verification Engineer (Silicon Engineering)
$165k - $260k
...actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars.SR. ASIC DESIGN VERIFICATION ENGINEER (SILICON ENGINEERING)At SpaceX we’re leveraging our experience in building rockets and spacecraft to deploy Starlink,...
Suggested
Permanent employment
Temporary work
Worldwide
Weekend work
SpaceX
Irvine, CA
3 days ago
ASIC Design Verification Engineer
...performance at critically important power efficiency. We are looking for highly skilled and efficient Constrained Random Design Verification engineers that want to verify new designs that can evolve rapidly at every generation in a very dynamic market using industry...
Suggested
Full time
Local area
Worldwide
Broadcom Corporation
Irvine, CA
3 days ago
Design Verification Engineering
...development, with a particular emphasis on highly energy-efficient design and new technologies that transform the user experience at the... ..., Design Verification, Test and Validation, and FW/SW engineering. As a Wireless SOC Design Verification Engineer, you’ll be at...
Suggested
Night shift
Apple
Irvine, CA
4 days ago
Module Design Engineer (BMS)
$129k - $171k
...defense industry, Anduril is changing how military systems are designed, built and sold. Anduril’s family of systems is powered by Lattice... ...to the military in months, not years.As a Senior Battery Engineer, you will drive the development of energy storage systems (ESSs...
Suggested
Full time
Work experience placement
Immediate start
Anduril Industries
Costa Mesa, CA
4 days ago
High Speed Design Engineer
High Speed Design EngineerLocation: Irvine, CAJob ID: #73340Pay Range: $55-61/hr 12 monthsMin years of experience: 6 yearsDegree Requirements: Engineering DegreeDetailed Job Description: High Speed Design EngineersHigh Speed Board Design & Testing Experience (6 to 10Years...
Suggested
Butler
Irvine, CA
1 day ago
Remediation Design Engineer
$79.9k - $139.8k
...manufacturing, turning abstract ideas into realities that transform the world for good. Your impact We’re seeking mid-level design engineers with a broad background in environmental site remediation for federal and global private sector clients.Based in the West...
Full time
For contractors
For subcontractor
Work at office
Remote work
Jacobs
Irvine, CA
13 hours ago
Design Engineer, DFM / DFA
$129k - $171k
...defense industry, Anduril is changing how military systems are designed, built and sold. Anduril’s family of systems is powered by Lattice... ...in months, not years.WHAT YOU’LL DOAs a Mechanical Design Engineer focused on DFM/DFA, you will sit at the critical intersection of...
Full time
Work experience placement
Immediate start
Anduril Industries
Costa Mesa, CA
4 days ago
Physical Design Engineer
...our offerings. We learn continuously, both on the job and through formal training programs.Job DescriptionJob Description:Physical design implementation at block or top level, low power techniques and timing closureJob Duties Include:- Will own all parts of the physical...
System Canada Technologies
Irvine, CA
3 days ago
Design Characterization Engineer
$110.6k - $140k
DescriptionWe are seeking a highly skilled Design Characterization Engineer to join our fast‑paced, innovation‑driven R&D team. In this role, you will characterize and optimize CMOS image sensor performance, collaborate closely across engineering disciplines, and help...
Omnivision Technologies
Irvine, CA
2 days ago
Design Verification Engineering
$143.8k - $230k
...In Create Account) 2. If you already have a Candidate Account, please Sign-In before you apply. Job Description: Design Verification Engineer Broadcom's ASIC Products Division (APD), a worldwide leader in the design of complex custom ASICs and embedded IP, is...
Full time
Local area
Worldwide
Broadcom Corporation
Irvine, CA
13 hours ago
ASIC Design Verification Engineer
...Responsibilities: Conceive and develop leadership silicon technology for data centers and cloud operators. Collaborate with a global design and architecture team to create world-class devices. Engage in all aspects of front-end design, including architecture...
AnySilicon
Irvine, CA
4 days ago
Senior RF Design Engineer, EW
$166k - $220k
...defense industry, Anduril is changing how military systems are designed, built and sold. Anduril’s family of systems is powered by... ...and assist with testing.Required QualificationsB.S. Electrical Engineering or equivalent6+ years experienceExperience with RF cascade analyses...
Full time
Work experience placement
Work at office
Immediate start
Anduril Industries
Costa Mesa, CA
4 days ago
Thermal Design Engineer
$112k - $149k
...defense industry, Anduril is changing how military systems are designed, built and sold. Anduril’s family of systems is powered by... ...to the military in months, not years.About the TeamThe Thermal Engineering team enables Anduril's rapid hardware development cycle by ensuring...
Full time
Work experience placement
Internship
Immediate start
Anduril Industries
Costa Mesa, CA
4 days ago
Design Engineer
$43 - $58 per hour
...Job Description Job Summary: This position is responsible for the delivery of engineering services, from conceptual design through construction completion of HVAC, Plumbing, and other contract services offered by the business. Essential Duties and Responsibilities...
Hourly pay
Contract work
Temporary work
For contractors
Work experience placement
Internship
Work at office
Local area
Monday to Friday
ACCO Engineered Systems
Costa Mesa, CA
4 days ago
Design Engineer
...Design Engineer Remilia is a multidisciplinary art studio and lifestyle brand building unconventional social applications. We produce underground culture events with emerging artists globally and are building a social media platform to connect these communities....
Full time
Remilia Corporation
Irvine, CA
13 hours ago
SoC Physical Design Engineer, PnR
...will be directly responsible for the physical implementation of design partition(s) (from netlist to tapeout) for a highly complex... ...Preferred Qualifications MS in Electrical/Electronics/Computer Engineering or related field Experience with large SOC designs (20M...
Apple
Irvine, CA
13 hours ago
Design Engineer
$115k - $140k
...Design Engineer TAE is the world's first private fusion energy company, founded in 1998 to commercialize the cleanest, safest, most affordable, and sustainable form of carbon-free power. We are applying science and engineering to design transformational technologies...
Work experience placement
Work at office
Flexible hours
TAE Technologies, Inc
Irvine, CA
2 days ago
DDR Design Engineer
$175k - $308.5k
...DDR Design Engineer At Apple, we work to craft products that enrich people's lives. If you're passionate about taking on unsolved challenges, we have a great opportunity for a results-oriented and highly motivated DDR Design Engineer. As a member of our dynamic group...
Relocation
Apple
Irvine, CA
1 day ago
Design Engineer II
...Job Title: Design Engineer II Duration: 1+ Year Contract Job Description We are seeking a skilled Design Engineer II to join our team in Irvine, CA. This role requires a hands-on mechanical engineer with experience in new product development, especially...
Contract work
Kasmo Global
Irvine, CA
4 days ago
Design Engineering S
$80k - $120k
...Civil Engineer A top engineering firm in the area is looking to add a Civil Engineer with 3+ years of design experience to their team. This company has an amazing in office culture, top notch clients, and makes very competitive offers. Design Engineer Responsibilities...
Work at office
gpac
Irvine, CA
4 days ago
RTL Design Engineer
$122.7k - $214.3k
...re passionate about taking on unsolved challenges, we have a great opportunity for a results-oriented and highly motivated RTL Design Engineer. This is an exciting position in the world class Apple mixed-signal silicon design team! This role will build upon your solid foundation...
Relocation
Apple
Irvine, CA
4 days ago
Sr. Design Engineer
$120k - $150k
...commercialize the cleanest, safest, most affordable, and sustainable form of carbon-free power. We are applying science and engineering to design transformational technologies. Whether it's harnessing fusion through the science of stars, making exponential leaps in power...
TAE
Irvine, CA
4 days ago
Sr. ASIC Design Engineer (Silicon Engineering)
$165k - $265k
...SpaceX is actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars.SR. RTL DESIGN ENGINEER (SILICON ENGINEERING)At SpaceX we’re leveraging our experience in building rockets and spacecraft to deploy Starlink, the world...
Permanent employment
Temporary work
Worldwide
Weekend work
SpaceX
Irvine, CA
13 hours ago
Sr. SOC/ASIC Physical Design Engineer (Silicon Engineering)
$165k - $260k
...developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars.SR. SOC/ASIC PHYSICAL DESIGN ENGINEER (SILICON ENGINEERING)At SpaceX we’re leveraging our experience in building rockets and spacecraft to deploy Starlink, the world...
Permanent employment
Temporary work
Worldwide
Weekend work
SpaceX
Irvine, CA
2 days ago
Design tech - engineering
...SpaceX is actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars.RFIC DESIGN ENGINEER (RFIC ENGINEERING)At SpaceX we’re leveraging our experience in building rockets and spacecraft to deploy Starlink, the world’s...
Permanent employment
Temporary work
Worldwide
Weekend work
SpaceX
Irvine, CA
1 day ago
Digital Design Engineer, Air Dominance and Strike
$146k - $194k
...defense industry, Anduril is changing how military systems are designed, built and sold. Anduril’s family of systems is powered by... ...ABOUT THE TEAM The Air Dominance and Strike (AD&S) Electrical Engineering Team develops high-reliability avionics, embedded processing,...
Full time
Work experience placement
Immediate start
Anduril Industries
Costa Mesa, CA
2 days ago
Sr. Digital Circuit Design Engineer
$130.6k - $160k
DescriptionKey Responsibilities:Design and implement sensor timing control logic and contribute to ISP system-level integrationParticipate... ...closely with CIS project leads and sensor digital/analog engineers for system integration and validationWork with physical design...
Omnivision Technologies
Irvine, CA
2 days ago
Sr. Digital Design Engineer
$120.6k - $150k
DescriptionWe are looking for Digital Design Engineer for design and development of next generation image sensors and related technologies. The candidate should have strong fundamentals in digital circuit design and ability to independently design blocks with given specifications...
Omnivision Technologies
Irvine, CA
3 days ago
Sr. RFIC Design Engineer (RFIC Engineering)
$165k - $265k
...is actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars.SR. RFIC DESIGN ENGINEER (RFIC ENGINEERING)At SpaceX we’re leveraging our experience in building rockets and spacecraft to deploy Starlink, the world’s...
Permanent employment
Temporary work
Worldwide
Weekend work
SpaceX
Irvine, CA
1 day ago
Sr Design Quality Engineer (Mechanical/Electrical)
Job Summary:Provides design quality engineering guidance and support for New Product Introduction (NPI) and/or Product Life Cycle Management (LCM) activities with a focus on product quality while ensuring compliance to company-wide Quality Management System and regulatory...
Contract work
Local area
Fortive
Irvine, CA
3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Design Engineer. Be the first to apply!