Outset Medical Mexico

Staff Software Engineer, Cloud Infrastructure

Requirements/Qualifications Master’s degree in computer science, or a similar field, or an equivalent combination of education (Bachelor’s degree) and related work experience. A minimum of 8+ years of professional experience in software development with hands on coding experience covering full stack and big data. Programming skills in one or more of: Java, Python, Scala, Typescript/Javascript, and SQL. Strong foundation in pragmatical computer science, with competencies in common data structures, algorithms, OOP, Functional Programming and software design and patterns. Problem solving and debugging skills. Experience in designing and developing RESTful APIs, data persistence APIs. Willing to pick up any languages, technologies, or methodologies necessary - and if a conventional solution does not exist, then roll up the sleeves and innovate as necessary. Expert with AWS. Familiarity with microservice architectures, containers and related DevOps technologies and concepts. Experience with: A variety of backend & database technologies and with making architectural trade-offs Large-scale distributed storage and database systems (RDBMS or NoSQL) Building real-time messaging solutions with core language features as well as AWS managed services and open-source turn-key solutions Distributed messaging systems Setting up server monitoring, alerting, logging and server provisioning Terraform, Ansible, Docker, AWS CDK, CloudFormation, EKS/Kubernetes or similar technologies. Developing and productionizing ML models AIOps/MLOps - cloud application and infrastructure predictive analytics: catch platform API, server, job failures before they happen Familiarity with one or more of: DynamoDB, S3, Kafka/Zookeeper, Kinesis, Postgres, Snowflake, Athena, MQTT, RabbitMQ, GraphQL, Avro, Protocol Buffers, Thrift, gRPC, nginx, AWS VPC, ALB, CloudWatch, CloudTrail, SQS, SNS, Cognito, Inspector, Lambda, Fargate, OWASP, STIG, Spark, Flink, SageMaker, MLFlow, TensorFlow, Scikit, etc.

Hace 5 horas en Tijuana

Manufacturing Engineer -NPI Lead

Required Qualifications S. in Industrial, Mechanical, Manufacturing Engineering, or related field. 7+ years of medical device manufacturing and NPI experience, including disposable/single-use products; capital equipment experience preferred. Advanced English Previous supervisory or team-lead experience Strong knowledge of FDA QSR, GMP, and ISO 13485. Proven experience leading cross-functional NPI programs in a regulated environment. Experience with high-volume manufacturing. Strong analytical, problem-solving, and communication skills. Proficiency with Microsoft Office, Minitab, and CAD tools (SolidWorks/AutoCAD). Desired Qualifications Lean Six Sigma Green Belt or higher. Experience with extrusion, injection molding, ultrasonic welding, tubing/sets, or electro-mechanical assemblies. Strong DFM/DFA and cost optimization background.

Hace 5 horas en Tijuana

Software Engineer (Cloud)

Master’s degree in computer science, or a similar field, or an equivalent combination of education (Bachelor’s degree) and related work experience. Strong backend engineering fundamentals with an appreciation for distributed, data-intensive systems A minimum of 3+ years of professional experience in software development with hands on core backend/cloud experience. Strong programming skills in one or more of: Java, Python, Scala, Typescript/Javascript. Strong foundation in pragmatical computer science, with strong competencies in common data structures, algorithms, OOP, Functional Programming and software design and patterns. Strong problem solving and debugging skills. Experience in designing and developing RESTful APIs, data persistence APIs. Experience with a variety of backend & database technologies. Willingness to learn new languages, tools, or methodologies as needed, and to innovate when conventional solutions do not suffice. Proficiency in building and deploying applications on AWS. Experience with SQA as well as large-scale distributed storage and database systems (RDBMS or NoSQL) Experience with distributed messaging systems. Experience building real-time messaging solutions using core language features, AWS managed services, or open-source frameworks. Familiarity with microservice architectures, containers and related DevOps technologies and concepts. Experience with setting up server monitoring, alerting, logging and server provisioning. Experience with Terraform, Ansible, Docker, AWS CDK, CloudFormation, or similar technologies. Familiarity with several of the following: DynamoDB, S3, Kafka/Zookeeper, Kinesis, Postgres, Athena, MQTT, RabbitMQ, GraphQL, Avro, Protocol Buffers, Thrift, gRPC, nginx, AWS VPC, ALB, CloudWatch, CloudTrail, SQS, SNS, Cognito, Inspector, Lambda, Fargate, OWASP, Spark, Flink, EKS/Kubernetes, etc.

Hace 5 horas en Tijuana

Senior Software Development Engineer in Test

Required Qualifications Bachelor's Degree in Electrical Engineering, Computer Engineering, or a related technical field, or equivalent combination of education and experience. Extensive experience with software quality engineering methodologies and processes. 4+ years of programming experience, leveraging AI libraries and tools to enhance and extend test automation frameworks. 2+ years of full-stack Software Test Engineering experience. 4+ years of experience utilizing AI tools and libraries to enhance test automation frameworks and build test fixtures for hardware interaction. 4+ years of hands-on experience in test automation using Python, Robot Framework with Appium, and Selenium. Strong understanding of testing methodologies and strategies, including black-box, grey-box, and white-box testing, as well as feature, functional, continuous integration, continuous deployment, continuous testing, and regression testing. Desired Qualifications Experience in performance and load testing for embedded and cloud applications. Experience implementing CI/CD pipelines for automated tests across different application layers. Strong background in developing and integrating test fixtures with automated tests using Python, Robot framework, or AI tools and libraries. Self-motivated, independent, and eager to learn new technologies. Detail-oriented, with strong time management skills and the ability to meet deadlines. Excellent interpersonal and teamwork skills, with the ability to work independently. Exceptional analytical skills and problem-solving abilities. Collaborate effectively with team members, both in person and virtually, with this role requiring regular work from the office. Flexible, able to work under tight deadlines in office environment, and support off-hours demands when needed.

Hace 5 horas en Tijuana

Senior Design Quality Engineer

Required Qualifications Bachelor’s degree in Engineering or Science (or similar) is required. Master’s degree is preferred. Minimum of 7 years of hands-on experience in the Quality Engineering discipline. Prior experiences in the medical device field is required; preferably experience with Capital Equipment and single use medical devices. Knowledge of FDA Quality System requirements, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards. Must be able to communicate fluently in both written and spoken English Desired Qualifications Ability to work effectively in a fast paced and dynamic environment. A self-starter, motivated and able to positively motivate others. Focused, target driven with a positive, can-do attitude. Drive to assigned objectives which delivers best practice results, added value and continuous improvements across the business and quality management system. Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers. Strong written and verbal communication skills. Certified Quality Engineer a plus. Lead Auditor certification a plus. Lean Certification a plus. Experience with statistical analysis software a plus

Hace 5 horas en Tijuana

Quality Complaint Analyst

Required Qualifications Bachelor’s degree in engineering or technical field or equivalent. Knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements. Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards. 1+ year experience working in a regulated industry or similar manufacturing and engineering environments preferred. Ability to work effectively in a fast paced and dynamic environment. Strong analytical skills. Proficient in MS Office, Visio, and Adobe Acrobat. Fluent in English (both written and verbal). Desired Qualifications. Excellent interpersonal skills. A self-starter, motivated and able to positively motivate others.

Hace 5 horas en Tijuana

Senior Quality Engineer (Disposables)

Required Qualifications Bachelor's degree in engineering or technical field or equivalent experience is required. Minimum of 5+ years of experience. Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971. Able to read and understand technical data. Competent using Microsoft Office suites. Strong written and verbal communication in English. Desired Qualifications Good analytical, communication (both verbal and written) and presentation skills. Statistical analysis software a plus. Effective analytical, technical, and problem-solving skills. Ability to multi-task and manage multiple assignments in a timely manner. Strong analytical skills. Quality engineering certification, Lean Six Sigma certification.

Hace 5 horas en Tijuana

Quality Systems Specialist

Required Qualifications Bachelor’s degree in engineering, medical, science, or equivalent experience. . Previous experience in the role can be considered. Minimum of 3 years of experience supporting quality systems within a regulated environment. Prior experience in the medical device field is required; preferably experience with disposable and capital equipment medical devices. Ability to work effectively in a fast-paced and dynamic environment. Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers. Fluent in English (written and verbal). Desired Qualifications Strong interpersonal skills and ability to work cross-functionally. Self-motivated with strong organizational skills. Strong written and verbal communication skills. Lead Auditor Certification preferred. Certification or training in Lean Six Sigma is a plus.

Hace 5 horas en Tijuana

Customer Technical Support Specialist

Essential Job Functions and Responsibilities: Provides technical and clinical support to customers and field personnel including Sales and Service. Maintains documentation and detailed reporting via electronic format in Salesforce (CRM), which includes case creation, detailed description of inquiry or problem, and clear customer resolution. Consults with Escalation Support Engineers as required and apply technical knowledge to diagnose problems. Maintains open communication with local support teams to ensure problem resolution and customer satisfaction. Maintains problem ownership & accountability until issues are resolved or handed off to another department. Follows up on problems, identifies recurring issues, process status, and follow through with customer. Coordinates and schedules remote software updates. Manages updating internal/external customer TabloHub accounts. Maintains a knowledge base of the products and services available to the customer. Operates within acceptable parameters and call handling expectations. Fosters positive customer relations by responding to complaints/inquires in a cooperative, supportive, and professional and efficient manner. Required Qualifications: Associate's degree in medical or technical field (preferred) with 1-2 years of experience or military equivalent. Two or more years of applicable experience may be substituted for the formal education requirement. Advanced English proficiency (spoken and written) required , including the ability to conduct technical conversations over the phone and accurately document cases in English. Regularly scheduled 8-hour shift, with additional on call, weekend, and holiday rotation. Possess solid customer service skills. Ability to ensure effective troubleshooting techniques with end users of various levels of technical expertise Demonstrated technical ability to comprehend technical issues and read technical manuals.

Hace 5 horas en Tijuana