System Engineer V&V(Hybrid)
hace 1 mes
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it
Job Title: Systems Engineer V&V
Department: Systems Engineering COE
FLSA Status: Exempt
Position Overview:
The Systems Engineer V&V is a member of the Systems Engineering COE and a technical expert responsible for leading Systems Engineering activities related to verification and validation of Insulet’s products. Education and work experience should encompass a wide array of engineering disciplines relevant to: mechanical testing, system testing, material testing, 3rd party (agency) testing, shelf life and aging testing, simulated use, and drug-device compatibility testing.
The position will report to the Manager Systems Design Verification, Systems Engineering COE, Medical Devices R&D located at Insulet’s Headquarters in Acton, MA.
Responsibilities:
Manage all Verification and Validation activities and deliverables for New Product Development and Lifecycle Project Teams.Develop detailed Verification schedules utilizing time based resourced management toolsPerform detailed requirements analysis and manage Test Cases and Test Runs using RQM Tools (DOORs, Helix, Jama).Participate in the planning and execution of technical project work.Create and document novel and robust test methodologies and provide feedback and recommendations for product/design changesAnalyze design changes implemented after execution of verification and validation to determine regression testing requiredManage 3rd party verification activities to ensure product is fully compliant with all applicable standards (i.e. IEC/AAMI/UL 60601-1, 1-2 and applicable collateral standards)Perform dry-running of new and updated Test CasesPerform systemic review of Test Cases to ensure that both typical use and edge cases are properly covered (happy-path, alternate path, negative path, etc.)Perform and maintain product configuration management for assigned projectsEnsure compliance with Insulet quality policies, procedures and practicesEnsure compliance with all local, state and federal regulations, policies and procuresEducation and Experience:
Minimum Requirements:
Bachelors’ Degree in Biomedical Engineering, Software Engineering, Computer Science, Mechanical, Electrical Engineering or a related field.Minimum of 3 years’ experience testing medical devices in a multidisciplinary project team environment or advanced degree and 1+ years of experiencePreferred Skills and Competencies:
Strong technical judgement with extensive technical leadership skillsDemonstrated capability of leading Verification & Validation Test ProgramsFamiliarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process.Sound knowledge of engineering first principalsStrong Analytical and Problem-Solving SkillsAbility to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teamsExperience in directing associates and leading small cross-functional teamsFamiliarity with System Level Testing of software based Medical Devices is a plusPrevious experience with National Instruments LabView, CVI, Test Stand and/or Measurement Studio is a big plusExcellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes development/verification/validation/procurement/manufacturing/regulatory and quality expertsDemonstrated skills developing and introducing innovative FDA-regulated medical devices (Class 2 or 3) under Design Controls is a plusExperience with design and development processes that conform to standards such as ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid
-
System Engineer V&V
hace 4 semanas
Tijuana, B.C., México Insulet Corporation A tiempo completoSystem Engineer V&V (Hybrid) page is loaded System Engineer V&V (Hybrid) Apply locations Aviacon, Tijuana time type Full time posted on Posted 3 Days Ago job requisition id REQ-2024-6026 Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product...
-
System Engineer V&V
hace 2 horas
Tijuana, México Insulet A tiempo completoInsulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are...
-
Associate Systems Engineer, V&V
hace 1 mes
Tijuana, México Insulet Corporation A tiempo completoInsulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.We are...
-
Quality Management System Engineer
hace 4 semanas
Tijuana, México Bose A tiempo completoJob Description As the incumbent of this Quality Management System Engineer role within Bose, your challenge will be to guide and support Bose business units and groups to always do the right thing according to IATF 16949 & ISO 9001 standards. The QMS engineer will assist Quality Management to ensure system compliance & preparations for Management Review....
-
Asesor Homeoffice Services Tijuana L-v
hace 1 mes
Tijuana, México Tres R A tiempo completo**Vacante para la empresa Tres R en Tijuana, Baja California**: AGENTE BILINGÜE / Servicio Al Cliente Radicas en TIJUANA, PLAYAS o TECATE está es tu oportunidad.... ¤ Nível intermedio/avanzado de inglés ¤Desde secundaria ¤ Experiência no requerida ¤ Sin límite de edad Provide customer service and receiving calls to confirm reschedule...
-
Project Engineer
hace 4 semanas
Tijuana, México Emprego MX A tiempo completoDescripción y detalle de las actividades Empresa líder en electrónicos e infraestructura ubicada en pacifico busca: Project Engineer Actividades: Planifica los proyectos y los recursos a su cargo Gestiona los recursos físicos, tecnológicos, humanos y financieros del proyecto Gestionar el coste y el presupuesto del proyecto Participar en la definición...
-
Quality Systems Engineer
hace 4 semanas
Tijuana, México Emprego MX A tiempo completoDescripción y detalle de las actividades Key responsibilities: -Define and oversee effective implementation of the Quality Management System. -Define and maintain the Quality Manuals and Procedures and ensure contents are appropriate for the company. -Perform gap analysis to detect opportunities areas to improve internal and external quality/manufacturing...
-
Quality Management System Engineer
hace 4 semanas
Tijuana, México Emprego MX A tiempo completoDescripción y detalle de las actividades Ensure compliance with the Quality Management System, in accordance with Bose QMS, applicable worldwide standards, for example IATF 16949 and ISO 9001. - Assist with implementing and maintaining a single worldwide Quality Management System (QMS) strategy. - Support the business during internal and external audits. -...
-
Embedded Systems Engineer
hace 1 mes
Tijuana, México TACNA A tiempo completoEddy Pump Corporation Descripción y detalle de las actividades Electrical or computer engineer, // C/C++ programming // Troubleshooting and embedded experience // Informacion de la empresa No especificado Información Extra Vacantes Abiertas 1 Turno L-J:7:00 - 5:30 V:7:00 - 3:00 City Tijuana Educación undefined Años de Experiencia null...
-
Opex Engineer
hace 4 semanas
Tijuana, México Emprego MX A tiempo completoDescripción y detalle de las actividades Empresa de clase mundial responsable de la manufactura de equipos eléctricos e infraestructuras industriales, busca: Opex Engineer Actividades: Análisis de proceso para mejora de los mismos Lidera proyectos de mejora continua en el área productiva Implementa herramientas lean en el área Identifica oportunidades...
-
Test Engineer
hace 1 mes
Tijuana, México Emprego MX A tiempo completo**Descripción y detalle de las actividades** - Responsible to design, validate, implement and sustain test systems; including documentation, training and statistical process control. An Engineer seeks and promotes the continuous improvement and automation of the test processes on current and transfers businesses.Optimize test process complying with customer...
-
V-planner Buyer
hace 7 días
Tijuana, México Emprego MX A tiempo completoDescripción y detalle de las actividades Vapotherm new company located at the Pacifico Industrial Parque. Medical assembly respiratory devices. Primary Responsibilities and desired experience: - Maintain and follow purchasing procedures to conform to ISO standards. - Interfaces w/Quality, Engineering, Customer Service, Management, etc. on a daily basis...
-
Manager, Systems Design Verification
hace 1 mes
Tijuana, México Insulet Corporation A tiempo completoInsulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.We are...
-
Manager, Systems Design Verification
hace 2 horas
Tijuana, México Insulet A tiempo completoInsulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are...
-
QA Hybrid Engineer
hace 1 día
Tijuana, México Gestion de Servicios Empresariales A tiempo completo**Summary** **Responsibilities** - Works as part of an Agile cross-functional team performing manual and hybrid no-code\lo-code automation testing of various items each sprint. - Utilizes tools such as TestIM, Postman, and\or SQL Query Analyzer to verify bugs and enhancements. - Documents and reports on issues found to the Quality Assurance, Development,...
-
Sr. Manufacturing Smt Engineer
hace 1 semana
Tijuana, México Emprego MX A tiempo completoDescripción y detalle de las actividades Empresa internacional dedicada a la electrónica busca Sr. Manufacturing SMT Engineer Actividades: Elabora layout de áreas de producción. Elabora y actualiza diagramas de flujo. Actualiza y corrige procedimientos de manufactura. Toma tiempos y balanceo de lineas. Realiza corridas para pruebas de diseno de...
-
V-planner Buyer
hace 4 semanas
Tijuana, México Emprego MX A tiempo completoDescripción y detalle de las actividades Primary Responsibilities and desired experience: - Maintain and follow purchasing procedures to conform to ISO standards. - Interfaces w/Quality, Engineering, Customer Service, Management, etc. on a daily basis communicating status and championing issue resolution. - Coordinate the timely disposition of NCMR’s and...
-
Embedded Engineer
hace 4 semanas
Tijuana, México Eddy Pump A tiempo completoEddy Pump Corporation is an international engineering and manufacturing company with state-of-the-art material moving technology that is used onboard US Navy Ships along with the largest mining, oil, wastewater, chemical, etc industries in the world. We are currently expanding rapidly and are looking for a talented new addition to our team. This person will...
-
Network Engineer
hace 4 semanas
Tijuana, México BAJA CALL CENTER A tiempo completoAs a network engineer, you'll be responsible for setting up, developing, and maintaining computer networks within an organization or between organizations. You'll offer support to users, who can be staff, clients, customers, or suppliers, and troubleshoot any problems that arise. This may, in some cases, involve designing new networks. Your aim is to ensure...
-
Early Career Leadership Engineer
hace 1 mes
Tijuana, México Emprego MX A tiempo completoDescripción y detalle de las actividades - The ECl Engineer; Will participate in a 3 defined rotation program to know our Business System and Values. Have requisite business and leadership skill to perform; understand our products; markets; customers and geographies. - The ECL Engineer will be a future Belden Leader Experiência y requisitos - Graduated...
