Lead Design Assurance Engineer - Medical Devices, ISO 14971
The Fountain Group
The Fountain Group is seeking a Lead Design Assurance Engineer to drive risk management activities for medical device development. You will own risk management files, work with Engineering, Marketing, Manufacturing and Regulatory, and ensure design controls and V&V are integrated throughout the lifecycle. The role requires a strong background in ISO 14971 risk management with hands-on experience in design assurance and quality engineering. #J-18808-Ljbffr The Fountain Group
- Experis is seeking an Engineer, Design Assurance in Pleasanton, CA for a 6-month on-site assignment in the medical device industry. You will support Risk Management and Product Development... ...Quality Systems Department, focusing on ISO 14971 guidelines and design verification...Suggested
- The Lead Design Assurance Engineer is responsible for following established GMP/ISO compliant quality system practices. Duties: Lead design... ...Risk Analysis) per ISO 14971 guidelines. Manage new risk... ...minimum 5+ years’ experience in Medical Device Design Assurance / Quality...Suggested
- ...today and address the medical challenges of... ...The Senior Quality Engineer, Medical Device External Quality is part... ...and Product Quality Assurance group and reports to... ...CMO site audits. Leads quality reviews with... ...Knowledge of QSR and ISO 13485. • Medical Device...SuggestedFull timeContract workTemporary workLocal area
- Our client, a leading organization in the medical device industry, is seeking an Engineer, Design Assurance to join their team. As an Engineer, Design Assurance, you will be part... ...risk management files in compliance with ISO 14971 guidelines. Manage and develop new risk...SuggestedTemporary workFlexible hoursShift work
- Title : Design Assurance Engineer Location : Pleasanton, CA Duration... ...compliance with GMP, ISO, and regulatory... ...Key Responsibilities Lead Risk Management activities... ...accordance with ISO 14971. Develop and... ...knowledge of ISO 14971 and medical device risk management principles...SuggestedTemporary workFlexible hoursShift work
$90k - $180k
...spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and... ...Title Senior Electrical Engineer, Medical Devices... ...project goals Support design reviews Support development... ...requirements of Abbott, FDA and ISO regulations Comply with...For contractorsRemote workWorldwide- Abbott in Pleasanton, CA is seeking a Design Assurance Engineer for a 6-month on-site assignment to implement and maintain Risk Management processes... ...assessments and compliance. The successful candidate will lead risk-management activities, develop hazard analyses, and...
- VP, Ops & Quality Assurance Benefits Medical, Dental, and... ...privately‑held medical device company focused... ..., processes, and lead the people of the... ...21 CFRPart 1271, ISO 13485, California... ...ensure compliance for design control and risk... ...Oversee use of engineering, scientific, and...Contract workWorldwide
$115.3k - $130k
...As a global provider of medical technologies, Teleflex is... ...functional team, the Quality Engineer III, Design Assurance is responsible for... ...assess the usability of a device throughout design and development... ...regulations such as ISO 13485, ISO 14971 and FDA 21CFR820. • Proficient...Full timeTemporary workLocal areaFlexible hours$146.34k - $222.56k
Associate | Full-time Engineering | Livermore, CA |... ...use of marijuana)Medical Exam: A job-... ...qualification plans, design requirement documentation... ...development, and lead the product... ...engineering and/or quality assurance and control.... ...possession of mobile devices in Limited Areas....Minimum wageFull timeFor contractorsLocal areaWork from homeRelocationFlexible hours1 day per week- ...company’s Quality Management Systems (QMS) ensuring compliance with ISO 9001:2015 and 21 CFR Part 820. You will oversee audits, CAPA,... ...a ten-plus year track record in quality management for medical devices, strong regulatory knowledge, and proficiency #J-18808-Ljbffr...
- ...’s student in Biomedical or Mechanical Engineering for a Co-op/Intern role to gain hands-on... ...techniques, process development, and design principles. The Co-op/Intern will support... ...program. This role offers exposure to medical device engineering in a collaborative environment...Internship
- Support the Design Quality Assurance team by ensuring medical devices, assemblies, and components meet engineering requirements Support product development activities by ensuring that finished devices are safe, reliable, and compliant to Calyxo quality and regulatory...
- ...SUMMARYThe Manager, Quality Assurance is responsible for leading and ensuring the... ...(21 CFR Part 820/QMSR), ISO 13485, and other global standards... ...Quality, Quality Engineering, and Inspection functions... ...Quality Assurance within the medical device or similarly regulated industry...Work experience placementWork at office
- ..., CA, seeks a Quality Systems Manager to lead the development, implementation, and maintenance of the company’s QMS to ensure medical device regulatory compliance. You will oversee audits... ...The role requires a strong background in ISO 9001:2015, 21 CFR Part 820, and ERP/IT...
- ...parts for semiconductor, medical devices, and advanced tech... ...Summary The Second Shift Lead is responsible for... ...specifications, and ISO/AS9100 requirements.... ...closely with the Quality Assurance Department to identify... ...required while working in designated manufacturing areas....All shiftsShift workAfternoon shift
- ...therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering... ...systems Contribute to the design, development, and testing of... ...Regulatory Affairs, Quality Assurance, Product Management, and...Full timeWork at office3 days per week
- Stark Pharma Solutions Inc is seeking an experienced Systems Engineer based in Pleasanton, CA. You will lead system integration for complex medical devices, focusing on the integration of hardware and software. The ideal candidate has a strong background in systems engineering...
- ...Description Calyxo, Inc. is a medical device company headquartered in Pleasanton... ...Summary: As a Senior Quality Assurance Technician, you will support the Design Quality Assurance team by... ...assemblies, and components meet engineering requirements. You will support product...Hourly payFull timeShift work
- ...YOU'D DO Quality Assurance: Provide... ...with FDA QMSR and ISO standards. Lead preparation and... ...with FDA MDR and device vigilance reporting... ...regulations. Act as or designate QA... ...processing of Moximed Medical Device Reports (... ...projects with R&D and Engineering to assure...Flexible hours
- ...Calyxo, Inc. is a medical device company... ...oriented Staff Quality Engineer to join our New Product... ...principles, design controls, project... ...21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC... ...with IEC 62304, assuring that a state of control... .... ~ Lead root cause investigations...Full timeRemote workShift work
- ...Calyxo, Inc. is a medical device company... ...software architecture design, implementation... ...and electrical engineering specialists... ...and define and lead implementation of... ...software quality assurance purposes ~ Strong... ....g., IEC-62304, ISO-13485 and ISO-14971 What We...Shift work
- ...requirements: • 7+ years of (QE) Quality Engineering test automation experience in developing... ...testing frameworks primarily on REST-Assured & Jersey JAX-RS. Added advantage skills... ...The engineer should have experience with designing automation framework in such a way that...
- A leading medical device company in California is seeking an experienced professional to lead Quality Assurance and Regulatory Affairs teams. This role requires 15+ years of experience in medical device quality assurance and strong leadership skills. The successful candidate...
$151.62k - $185.64k
...testing for use of marijuana)Medical Exam: Not applicable... ...Cloud FinOps Lead to join the Computing organization... ...Partner with finance, engineering, cloud operations, and... ...environment to design, develop, implement, and... ...or possession of mobile devices in Limited Areas. Depending...Minimum wageFull timeFor contractorsWork at officeLocal areaWork from homeRelocationFlexible hours1 day per week- ...Pleasanton, CA is seeking a Senior Regulatory Affairs Specialist to support worldwide submissions and regulatory strategies for medical devices. The role collaborates with product teams and manufacturing to prepare filings and maintain licenses, registrations, and...Worldwide
$172k - $344k
...the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...plans for supplier controls to assure design, development and manufacture of... ...Substantial knowledge of FDA and ISO Quality System Requirements and...- ...Principal Supplier Quality Engineer is the company’s... ...Quality Engineer leads complex supplier quality... ...practices with FDA QMSR, ISO 13485, ISO 14971, and industry best... ...-10 years of Quality Assurance and/or Supplier... ...experience within the medical device industry.Strong working...Contract workWork experience placementWork at office
$104k - $231k
...dedicated to excellence in the design and engineering of Lam's etch and deposition... ...and following through to assure proper release and hand off... ...tools, and equipment.Experience leading cross-functional teams.... ...disability, mental disability, medical condition, genetic...Local areaRemote workFlexible hours2 days per week3 days per week1 day per week$32 per hour
...Lead Medical Assistant III Pleasanton, CA 94588 Overview Salary Range $32.00 - $3... ...Willing to work in Pleasanton and other designated Axis health centers based on clinic needs... ...privacy and dignity of agency clients; assure client confidentiality per HIPAA (...Hourly payFull timeWork at officeRemote workRotating shiftAfternoon shift
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