- 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 tools
- Perform 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 changes
- Analyze design changes implemented after execution of verification and validation to determine regression testing required
- Manage 3rd party verification activities to ensure product is fully compliant with all applicable standards (i.e. IEC/AAMI/UL , 1-2 and applicable collateral standards)
- Perform dry-running of new and updated Test Cases
- Perform 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 projects
- Ensure compliance with Insulet quality policies, procedures and practices
- Ensure compliance with all local, state and federal regulations, policies and procures
- 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 experience
- Strong technical judgement with extensive technical leadership skills
- Demonstrated capability of leading Verification & Validation Test Programs
- Familiarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process.
- Sound knowledge of engineering first principals
- Strong Analytical and Problem-Solving Skills
- Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams
- Experience in directing associates and leading small cross-functional teams
- Familiarity with System Level Testing of software based Medical Devices is a plus
- Previous experience with National Instruments LabView, CVI, Test Stand and/or Measurement Studio is a big plus
- Excellent 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 experts
- Demonstrated skills developing and introducing innovative FDA-regulated medical devices (Class 2 or 3) under Design Controls is a plus
- Experience with design and development processes that conform to standards such as ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971
-
System Engineer V&v
hace 3 semanas
Insulet Corporation Tijuana, MéxicoInsulet 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 ...
-
Associate Systems Engineer, V&v
hace 3 semanas
Insulet Corporation Tijuana, MéxicoInsulet 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 ...
-
V-manufacturing Engineer
hace 4 días
Ivemsa Tijuana, Méxicoy detalle de las actividades · Experiência y requisitos · - BS science in Engineering, preferably Mechanical or industrial - 3 years' experience in the field preferable - Able to work with Microsoft Office - Bilingual: Spanish 100%, English 85% - Have passport / US visa - Able to ...
-
System Engineer V&V
hace 2 semanas
Insulet Corporation Tijuana, MéxicoSystem 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 Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom ...
-
Asesor Bilingüe Clientes L-v T I J U a N a 23k
hace 3 semanas
Tres R Tijuana, México**Vacante para la empresa Tres R en Tijuana, Baja California**: · trabaja para nuestros clientes · AGENTE BILINGÜE / Servicio Al Cliente · Radicas en TIJUANA, PLAYAS o TECATE está es tu oportunidad.... · ZONA LABORAL: en Sitio Zona Urbana Tijuana. · ¤ Nível intermedio/avanzado de ...
-
System Engineer V&V(Hybrid)
hace 3 semanas
Insulet Corporation Tijuana, México De jornada completaInsulet 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 ...
-
Associate Systems Engineer, V&V
hace 2 semanas
Insulet Corporation Tijuana, México De jornada completaInsulet 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 ...
-
Maintenance Mechanic V
hace 2 semanas
TE Connectivity Tijuana, MéxicoTE Connectivity's Maintenance Teams perform repairs and preventive maintenance to ensure longer lifespan of machines and facilities. Every team member is responsible for maintaining housekeeping and organization of the work area as well as following TE Connectivity's EH&S policie ...
-
Administrative Support V
hace 2 semanas
TE Connectivity Tijuana, MéxicoTE Connectivity's Administrative Support Teams are responsible for office administration and daily clerical duties including basic schedule planning, travel arrangements, documentation, and file maintenance. Other responsibilities include scheduling conferences/meeting rooms and ...
-
Maintenance Mechanic V
hace 1 semana
TE Connectivity Tijuana, MéxicoTE Connectivity's Maintenance Teams perform repairs and preventive maintenance to ensure longer lifespan of machines and facilities. Every team member is responsible for maintaining housekeeping and organization of the work area as well as following TE Connectivity's EH&S policie ...
-
Maintenance Mechanic V
hace 3 días
TE Connectivity Tijuana, MéxicoTE Connectivity's Maintenance Teams perform repairs and preventive maintenance to ensure longer lifespan of machines and facilities. Every team member is responsible for maintaining housekeeping and organization of the work area as well as following TE Connectivity's EH&S policie ...
-
Operador Clase V
hace 3 semanas
Ensambles Hyson, S.A. de C.V. Tijuana, Méxicoy detalle de las actividades · El operador clase V deberá contar con conocimientos detallados de extrusión y ensamble. Capaz de realizar todo el montaje de modelos de producción. Responsables de la capacitación y la supervisión del trabajo de los ensambladores y operadores. Comun ...
-
V- Npi Engineer
hace 2 días
Buscojobs México Tijuana, Méxicoy detalle de las actividadesExperiência y requisitos- A Bachelor's Degree in Engineering or a related field of study - Experience with CM or OEM manufacturing including 2 years working regularly with one or more factories on process development, DFM, tooling readiness, and NPI pr ...
-
V-Manufacturing Engineer
hace 2 días
Ivemsa Tijuana, Méxicoy detalle de las actividadesExperiência y requisitos- BS science in Engineering, preferably Mechanical or industrial - 3 years' experience in the field preferable - Able to work with Microsoft Office - Bilingual: Spanish 100%, English 85% - Have passport / US visa - Able to trave ...
-
Maintenance Mechanic V
hace 3 días
TE Connectivity Tijuana, MéxicoTE Connectivity's Maintenance Teams perform repairs and preventive maintenance to ensure longer lifespan of machines and facilities. Every team member is responsible for maintaining housekeeping and organization of the work area as well as following TE Connectivity's EH&S policie ...
-
Farmacéutico L-v
hace 1 semana
Consultorio Médico Privado Tijuana, México**Vacante para la empresa Consultorio Médico Privado en Tijuana, Baja California**: AUXILIAR DE FARMACIA · ¤Prepa concluida o superior · ¤ Experiência en farmacia · ¤ Sin límite de edad · ¤ Inglés básico (CAPAZ DE MANTENER UNA CONVERSACIÓN SIMPLE) · *GANA inicial $10000 mensual*+ ...
-
Ejecutivo Bilingüe L-v
hace 1 semana
Agencia de reclutamiento Tijuana, México**Vacante para la empresa Agencia de reclutamiento en Tijuana, Baja California**: · AGENTE BILINGÜE LUNES A VIERNES · Radicas en Baja California, está es tu oportunidad.... · ¤ Nível intermedio/avanzado de inglés · ¤Desde secundaria · ¤ Experiência no requerida · ¤ Sin límite de ...
-
Ejecutivo Bilingüe L-v
hace 2 semanas
Agencia de reclutamiento Tijuana, México**Vacante para la empresa Agencia de reclutamiento en Tijuana, Baja California**: · AGENTE BILINGÜE LUNES A VIERNES · Radicas en Baja California, está es tu oportunidad.... · ¤ Nível intermedio/avanzado de inglés · ¤Desde secundaria · ¤ Experiência no requerida · ¤ Sin límite de ...
-
Ejecutivo Bilingüe L-v
hace 2 semanas
RS SA Tijuana, México**Vacante para la empresa RS SA en Tijuana, Baja California**: · AGENTE BILINGÜE LUNES A VIERNES · Radicas en Baja California, está es tu oportunidad.... · ¤ Nível intermedio/avanzado de inglés · ¤Desde secundaria · ¤ Experiência no requerida · ¤ Sin límite de edad · Actividad: l ...
-
Auxiliar en Farmacia L-v
hace 3 semanas
hospital ingenes Tijuana, México**Vacante para la empresa hospital ingenes en Tijuana, Baja California**: AUXILIAR DE FARMACIA · ACTIVIDADES: · - Realizar inventarios de los medicamentos y llevar el registro de humedad y temperatura de medicamentos de temperatura ambiente y red fría. Verificar y asegurarse de q ...
System Engineer V&V (Hybrid) - Tijuana, México - Insulet
Descripción
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:
Education and Experience:
Minimum Requirements:
Preferred Skills and Competencies:
NOTE: 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