Position Overview

The Junior CAD Designer is responsible for the creation of mechanical CAD assemblies and 2-D drawings for use by Engineering and Field Service Technicians to identify parts and assemblies within the Tablo family of products.  The Designer works collaboratively with, and under the supervision of, senior R&D, Manufacturing Engineering, and Document Control staff to align Solidworks data with Agile PLM Bills of Materials, create and maintain matching assemblies, drawings and BOMs, and create Engineering Change Orders to release documentation.

Essential Job Functions and Responsibilities

• Creates and/or revises Solidworks assemblies to match released BOMs in Agile, using Solidworks mates between features.
• Creates or imports 3D parts for simple components such as fittings and fasteners. Uses Agile to identify suppliers of components and sources CAD files when available.
• Inspects product samples and creates 3D models of cable harnesses and plumbing to show correct routing within the assemblies.
• Creates full assembly drawings, with exploded views and part identification bubbles that match Agile BOM items.
• Revise and update drawings based on feedback or engineering changes.
• Uses Solidworks Enterprise PDM Vault to Check-out/Check-in all files and control revisions.
• Prepares PDF exports of all drawings created for submission to Engineering Change Orders
• Creates Engineering Change Orders in Agile to release documentation for use.
• Ensure all deliverables meet internal standards and deadlines.
• Proactively seeks out answers to questions and gathers the information necessary to complete tasks.

Required Qualifications  

• 2-4 years experience creating and modifying parts, assemblies, and drawings using SolidWorks.
• Experience creating exploded views, BOMs, and manufacturing-ready documentation.
• Ability to interpret engineering sketches, redlined drawings, specifications, and design intent.
• Ability to adapt to BOM changes that may occur in parallel
• Collaborates with internal teams in the USA and Mexico (R&D, Supply Chain, Manufacturing, Document Control) to ensure alignment.
• Experience in mechanical design and drafting using SolidWorks.
• Experience with SolidWorks PDM or similar data management tools.
• With supervision, has ability to complete assigned tasks and meet project milestones.
• Familiarity with drafting standards and conventions (ANSI/ASME Y14.5)
• Strong technical English language skills, written and verbal

Desired Qualifications .

• 2-4 years’ experience, Associates Degrees, technical training, or equivalent, or college degree in progress
• Experience with Solidworks 2022 or newer, Enterprise PDM, and Cable and Tube Routing package
• Experience with Agile PLM for Change Orders
• Certified Solidworks Design Professional (CSWP)

Position Overview:

The Senior Software Quality Engineer is responsible for performing design assurance activities for new introductions and sustaining of medical device software, with the purpose of supporting the Software R&D, Test and Manufacturing departments. The incumbent for this position will support the Software Development Lifecycle of one or more projects from concept generation through production. This person will work closely with software design, software testing, project management, product management, regulatory, human factors, and manufacturing teams to understand and influence the architecture, requirements, detail design, testing, safety and cybersecurity risk evaluation and deployment of the software designs to the market.

This person must be versatile to support other design assurance activities such as data analysis, problem solving/ failure analysis, full QMS compliance and alignment with the software development practices, Business Process Optimization initiatives and continuous improvement to the Quality Management System. Additionally, this person must be able to perform as a Quality Assurance representative for hardware and disposable-related projects to support system-level reliability improvements when needed. They also help guide and mentor other team members in a collaborative environment.

Essential Job Functions and Responsibilities 

• Work closely with Regulatory, R&D, Test and Manufacturing, to ensure the adoption and use of best practices, Quality tools, and Design Control methodologies
• Support Software Quality Assurance (SQA) strategy and operational execution plans
• Knowledge of and experience in developing and medical devices in conformance with Quality System Regulations, ISO13485, ISO14971, ISO62304 and SW96 requirements.
• Applies knowledge of IEC 62304 to product development and sustaining engineering projects.
• Engage with the development team to align best practices and techniques for automated unit and integration testing.
• Continuously monitor customer feedback and report defects found through defect tracking system, provide necessary information to reproduce the defect to arrive at a solution.
• Serve as primary quality representative on one or more teams and projects for software, hardware, disposables, and system changes.
• Lead / Contribute to all elements of safety and cybersecurity risk management. Assesses risk by facilitating the development of risk management tools and contribute to the completion of the overall product risk management file.
• Support Design Verification and Validation planning & execution, including active cross-functional root cause analysis investigation & resolution activities. Develop and execute system related verification and validation plans and protocols, and test reports for medical and non-medical device software.
• Identify product quality and quality system improvement opportunities and drive procedure updates when required.
• Support departmental effort in CAPA investigation and completion.
• Collect, analyze, trend, and communicate quality data throughout the organization for proper escalation and applicable resolution.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Develop and maintain strong relationships with internal and external stakeholders
• Excellent interpersonal skills
• A self-starter, motivated and able to positively motivate others
• Focused, target driven with a positive, can-do attitude
• Support internal and external audits
• Support additional activities, as assigned

Required Qualifications 

• Bachelor’s degree in Computer or Engineering Science, Electrical or Software Engineering (or similar) is required. Master’s degree preferred.

• Minimum of 5 years of hands-on experience in the Quality Engineering discipline.

• Prior experience in the medical device field is required; preferably experience with Capital Equipment medical devices with embedded software and/or digital health initiatives is required.
• 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.
• Thorough knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971 (Risk Management) requirements, ANSI/ AAMI SW96, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
• Strong written and verbal communication skills.
• Must be able to communicate fluently in both written and spoken English

Desired Qualifications

• 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.

• Certified Quality Engineer a plus.
• Lead Auditor certification a plus.
• Lean Certification a plus.
• Experience with statistical analysis software a plus.

Position Overview 

We work diligently at Outset to ensure our Tablo™ system delivers the best possible user experience to our customers and you will contribute directly to this mission in your role. We are looking for an experienced Android Software Engineer who is passionate about software engineering and continuing to grow their skills. Ideal candidates must have excellent problem-solving skills, strong organization skills, strong written and verbal communication skills, and a high degree of attention to detail and a proven track record developing or implementing complex native Android applications.

Responsibilities/Functions 

• Collaborate with clinical experts, product managers and UX designers to understand customer requirements and develop best-in-class user experiences for healthcare professionals and home users. 
• Develop and deliver high complexity Android User Interfaces using Java, Kotlin and XML. 
• Participate in requirements definition, software architecture and detailed design, implementation, documentation, and software verification and validation. 
• Integrate Android applications with complex embedded control software over serial and Ethernet interfaces. 
• Define tasks associated with all phases of software development and provide accurate estimates of required effort and project completion dates. 

Required Qualifications

• B.S. in Computer Science/Engineering with 7 years of experience or M.S. in Computer Science/Engineering with 5 years of experience creating complex native Android applications. Strong candidates with less experience or education will be considered. 
• Experience integrating custom graphical and video assets into Android applications..
• Strong understanding of Android layout implementation, including Data Binding. 
• Strong knowledge of Android SDK, different versions of Android.
• Strong understanding of object-oriented design principles. 
• Proficient understanding of code versioning tools, such as Git
• Proficiency in Java, at least 3 years of experience working with complex Java applications. 
• Communicate clearly and effectively both orally and in writing with people having diverse backgrounds of knowledge and experience. 
• Ability to balance multiple concurrent projects and work well with minimal supervision. 
• Advanced English.

Desired Qualifications

• Demonstrated proficiency with Linux operating systems, including experience navigating and manipulating the Linux file system, leveraging command-line utilities and system directories to monitor hardware metrics, perform file system operations, and troubleshoot system performance.
• Experienced in building Android Images (AOSP), applying security patches, and performing custom system-level customizations as needed.
• Deep knowledge of unit and integration testing methodologies and implementations. 
• Experience with testing frameworks like Junit and Espresso.
• Experience in the medical device industry and FDA regulations.
• Experience with dependency injection frameworks, preferably Dagger-Hilt
• Database management, preferably utilizing Room
• Experience with MVVM + Clean architecture
• Experience interfacing with embedded software over serial and Ethernet protocols. 
• Familiarity with/experience in Kotlin. 
• Skills in Python, Groovy, Shell, C/C++.
• Skills in Gradle, Jenkins, Docker.
• Knowledge of UML. 
• Experience with Agile Scrum methodology. 

Position Overview  

We are looking for an experienced professional who helps provide an accurate measure of product quality through effective processes and software automation, while continually improving testing throughout the software development life cycle. This person applies both practical and theoretical knowledge in Computer Science, along with previous experience in healthcare or a related industry. Additionally, the individual is expected to have the ability to architect, create, and execute both manual and automated tests across different layers of embedded and cloud applications.

Essential Job Functions and Responsibilities

• Leverage programming skills and test fixture knowledge to design, develop, maintain, and extend software automation frameworks for embedded and cloud applications.
• Collaborate with the team to design, execute, and maintain both manual and automated test scripts across UI, backend, API, performance, scalability, and security layers based on project requirements.
• Establish and enforce quality standards, ensuring they align with project goals and application areas under control.
• Engage with developers, subject matter experts, cross-functional teams, and product management in test case reviews and execution.
• Integrate automated tests into the CI/CD pipeline, ensuring results are stored in a shared repository.
• Translate business requirements into testable features and create test scenarios that meet those needs.
• Identify, troubleshoot, and document reproducible defects, working to resolve issues efficiently with software development team members.
• Create and manage functional, non-functional, and integration testing environments; conduct root cause analysis and debugging for features with moderate complexity.
• Lead discussions with cross-functional team members to identify high-risk areas early in the development lifecycle and create strategies to mitigate those risks.
• Develop test plans, audit execution evidence, and generate test reports, adhering to structured and controlled processes.
• Analyze and verify data conversions across multiple formats to ensure accuracy and compliance with EMR systems.
• Mentor junior team members and contribute to the continuous improvement of software quality methodologies and processes.
• Lead process improvements, manage Jira verification, and facilitate CCB meetings with cross-functional teams to drive consensus and project alignment.
• Troubleshoot complex issues in existing or new software by analyzing both product behavior and code.

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, Robotframework, 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.
• Fexible, able to work under tight deadlines in office environment, and support off-hours demands when needed.

**Relocation support may be available for qualified candidates who are open to moving to the role’s location (Tijuana, BC).**

 Position Overview

The NPI lead coordinates New Product Introduction (NPI) activities from development through manufacturing transfer and production ramp for both capital equipment and disposable medical devices. This role provides technical and people leadership to NPI and/or Manufacturing Engineers and serves as the manufacturing owner for NPI programs, ensuring products are manufacturable, scalable, compliant, and delivered on time, cost, and quality targets.

The NPI Lead partners closely with R&D, Quality, Supply Chain, Operations, PMO, Regulatory, and external suppliers/CMs to drive successful product launches in a regulated medical device environment.

Essential Job Functions and Responsibilities

• Lead and supervise NPI and/or Manufacturing Engineers supporting new product programs.
• Own manufacturing readiness for NPI programs from concept through production release and ramp-up.
• Serve as the primary manufacturing interface to R&D, driving DFM/DFA, cost optimization, and risk reduction throughout development.
• Develop and scale manufacturing processes, tooling, fixtures, equipment, and test methods for capital and disposable products.
• Ensure execution of process and equipment validation (IQ/OQ/PQ, MSA) in compliance with FDA QSR, GMP, and ISO 13485.
• Partner with PMO to manage schedules, resources, risks, and timelines; proactively identify opportunities to accelerate launches.
• Lead pilot builds, early production runs, and transitions to Operations.
• Provide leadership for technical issue resolution, including NCs, CAPAs, yield loss, and early production challenges.
• Engage suppliers and Contract Manufacturers to support development, qualification, and manufacturing transfer.
• Ensure completion and compliance of manufacturing documentation (work instructions, BOMs, routings, PFMEAs, control plans).
• Track NPI performance metrics (yield, scrap, readiness, cost) and drive continuous improvement across launches

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.

Position Overview  

The Senior Software Developer in Test Engineer is an experienced professional who participates in providing accurate measure of product quality, processes, software automation, and continually help improve testing throughout the software development life cycle. This person applies their practical and theoretical knowledge from Computer Science and previous experience in healthcare or a related industry.   Additionally, the person is expected to have the ability to architect, create, and run both manual and automated tests for different layers of embedded and cloud application.

Essential Job Functions and Responsibilities

• Leverage programming skills and test fixture knowledge to design, develop, maintain, and extend software automation frameworks for embedded and cloud applications.
• Collaborate with the team to design, execute, and maintain both manual and automated test scripts across UI, backend, API, performance, scalability, and security layers based on project requirements.
• Establish and enforce quality standards, ensuring they align with project goals and application areas under control.
• Engage with developers, subject matter experts, cross-functional teams, and product management in test case reviews and execution.
• Integrate automated tests into the CI/CD pipeline, ensuring results are stored in a shared repository.
• Translate business requirements into testable features and create test scenarios that meet those needs.
• Identify, troubleshoot, and document reproducible defects, working to resolve issues efficiently with software development team members.
• Create and manage functional, non-functional, and integration testing environments; conduct root cause analysis and debugging for features with moderate complexity.
• Lead discussions with cross-functional team members to identify high-risk areas early in the development lifecycle and create strategies to mitigate those risks.
• Develop test plans, audit execution evidence, and generate test reports, adhering to structured and controlled processes.
• Analyze and verify data conversions across multiple formats to ensure accuracy and compliance with EMR systems.
• Mentor junior team members and contribute to the continuous improvement of software quality methodologies and processes.
• Lead process improvements, manage Jira verification, and facilitate CCB meetings with cross-functional teams to drive consensus and project alignment.
• Troubleshoot complex issues in existing or new software by analyzing both product behavior and code.

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, Robotframework, 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.
• Fexible, able to work under tight deadlines in office environment, and support off-hours demands when needed.