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CathX
San Jose
Job Description Job Description Purpose of Position : The Senior Design Assurance (DA) Engineer works as an integral part of the CathX Medical engineering team responsible for designing and manufacturing high quality medical products. The Sr. DA is the leading voice of quality in new product development, technology transfers, and process develo
Job Source: CathXAbbott Laboratories
Milpitas, CA, United States
Design Assurance Engineer II page is loaded Design Assurance Engineer II Apply locations United States > Milpitas : 1820 McCarthy Blvd time type Full time posted on Posted 14 Days Ago job requisition id 31079494 Abbott is a global healthcare leader that helps people live more fully at all stages
Job Source: Abbott LaboratoriesGlooko
Palo Alto, CA, United States
This position is responsible for developing, establishing, and maintaining quality and compliance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards, agency regulations, Glooko’s Quality Policy, Quality Objectives, and Quality Manual. About the Role: Support a
Job Source: GlookoOutform Inc
Union City, CA, United States
The Design Engineer transforms visualized concepts into manufacturing-ready drawings and provides essential knowledge for manufacturing materials, processes and cost. They are involved in checking prototypes and first articles, and presenting them to clients as appropriate. Traveling to suppliers or clients may be required, as needed. The Design En
Job Source: Outform IncHirebridge
Union City, CA, United States
The Design Engineer transforms visualized concepts into manufacturing-ready drawings and provides essential knowledge for manufacturing materials, processes and cost. They are involved in checking prototypes and first articles, and presenting them to clients as appropriate. Traveling to suppliers or clients may be required, as needed. The Design En
Job Source: HirebridgeGlobal Jupiter
San Jose, CA, United States
Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever Responsibilities will include, but are not limite
Job Source: Global JupiterInnogrit
San Jose, CA, United States
Job Description Job Description Salary: DOE Job description Contribute to micro-architecture designs for state-of-the-art high-speed low-power digital IPs. Implement design modules using hardware description language (HDL). Design schemes for multi-clock domain crossing and synchronization. Drive OVM/UVM design verification and support FPGA engine
Job Source: InnogritMidas Consulting
Santa Clara, CA, United States
Title: Design Engineer Location: Santa Clara, CA (Day one on-site) Required Skills/Experience: Professional Experience 5-6 Years Create concepts and DFM compliant 3D models & assemblies using Solidworks. Proficiency in Solid works-Routing, Weldments & basic knowledge of Simulation & Analysis. Exposure on Material selection and component ma
Job Source: Midas ConsultingSanta Clara, CA, United States
[Full Time] Design Assurance Engineer at Uh-Oh Labs (United States) | BEAMSTART Jobs Design Assurance Engineer Uh-Oh Labs United States
Date Posted
15 Nov, 2022
Work Location
Santa Clara, CA, United States
Salary Offered
$101000 — $120000 yearly
Job Type
Full Time
Experience Required
6+ years
Remote Work
Yes
Stock Options
No
Vacancies
1 available
Summary: Design, implement and review test plans and protocols to ensure that medical device/equipment products meet all quality standards. Oversee product quality throughout the entire product design realization process. Work closely with research and development to support new product development and improve product design. Investigate non-conformances and suggest changes as necessary. Work under general supervision with latitude for independent judgment. Required to consult with senior peers on certain projects as required.
Responsibilities of this Role: Support and monitor new product development project needs in design controls for adherence to the internal quality management system and all ISO, FDA, and QSR regulations.
Drive and ensure proper design controls are appropriate during design reviews.
Manage input to operations regarding quality issues such as process improvements and risk (DFMEA & PFMEA) updates.
Manages the pre- & post-production Design Assurance / Quality Engineering activities as they relate to product lifecycle development
Review and approve test verification / validation protocols and reports. Work with Supplier Quality and Supply Chain groups to ensure product suppliers are effectively developed.
Verify configuration management and Risk Analysis records are properly addressed, accurate, and maintained.
Provide expertise in the interpretation of regulatory requirements, such as those from the FDA, etc.
Ensure design changes are processed in accordance with current change-control requirements.
Manage and complete assigned tasks on schedule and identify and propose resolution for issues that may affect the timeline for remediation activities.
Provide quality engineering support for investigations as required.
Coordinate resolution of potential quality assurance deficiencies discovered during the product realization process.
Support CAPA investigations, reviews, approvals, and/or CAPA plan implementations as required.
Other Duties: Please note this job description is designed to cover a majority (but not all) of the activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without advance notice.
Required Skills and Qualifications: Bachelor's degree with a minimum of 5-7 years of experience in medical device design controls.
Experience in startup organization is a plus.
Demonstrated and impactful experience in product and process validation, software validation (device & quality system support), test method validation, Statistics, Risk Management Tools and Process Control & Monitoring (SPC).
Ability to interpret trends and data, translating the information into actions, outcomes and improvements
Excellent documentation skills, with a solid process orientation and effective attention to detail
Strong verbal and written communication skills a must.
Strong interpersonal skills with the aptitude to be a team player; setting a professional tone and establishing a cooperative partnership within the department and other areas of the company
Independent critical thinker, with the aptitude to work autonomously
Proficiency in all MS Office products
Quality engineering certification (ASQ CQE or CQA) desired
Knowledge of lean six sigma manufacturing processes
Supervisory Responsibility: This position does not have supervisory responsibilities.
Work Environment: This job works Hybrid (remotely / HQ)
EEO Statement: EOE/Vet/Disabled
About Uh-Oh Labs Accurate, low-cost diagnostic tests & platform for the home and clinic Company Size: 11 - 50 People Year Founded: 2018 Country: United States Company Status: Actively Hiring Looking for Partners Looking for Clients Raising Funds Share This Job
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Design Assurance Engineer jobs in Santa Clara, CA, United States
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
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