Associate Validation Engineer - Test Automation

About Sequel

Sequel, headquartered in Manchester, New Hampshire, is a company developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel’s flagship product, the twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type 1 diabetes providing them with personalized diabetes management.

Job Overview

Sequel Med Tech is seeking an Associate Validation Engineer – Test Automation to join our growing Salesforce Engineering team. This early-career role is designed for a software professional with foundational knowledge of computer science or software development who will apply those skills to design, develop, analyze, and maintain automated test programs in a regulated GxP and medical device environment. You will spend most of your time writing code, and using AI-assisted development tools to write code, that automatically tests our Salesforce configurations and integrations. No prior validation or regulatory experience is required: Sequel will provide structured training, mentorship from senior validation and engineering staff, and ongoing support as you learn Computer System Validation (CSV), Computer Software Assurance (CSA), and FDA requirements. The ideal candidate is curious, detail-oriented, comfortable learning new technologies quickly, and excited to build automated tests that help ensure our systems are safe, reliable, and compliant.

Job Responsibilities and Essential Duties

Under the guidance of senior validation and engineering team members, support day-to-day validation and test automation activities for Sequel's Enterprise Systems. This includes:

• Design, write, and maintain automated test scripts and test suites that verify Salesforce configurations, workflows, and integrations against documented requirements.
• Use AI-assisted coding tools (e.g., Cursor and similar) to accelerate test development, while reviewing, understanding, and taking ownership of all generated code.
• Translate user and functional requirements into clear test cases, ensuring traceability and comprehensive test coverage.
• Execute automated and manual tests, analyze results, and document defects with clear, reproducible detail.
• Integrate automated tests into CI/CD pipelines so that testing runs consistently as part of the development and release process.
• Learn and apply Computer System Validation (CSV) and Computer Software Assurance (CSA) practices in compliance with FDA 21 CFR Part 11, ISO 13485, and Sequel's quality procedures.
• Help prepare validation deliverables such as test plans, test protocols, traceability matrices, and summary reports under the direction of senior validation staff.
• Support change management by helping assess the testing impact of configuration changes to validated systems.
• Collaborate with full-stack engineers, Salesforce developers, product managers, and Quality partners to understand requirements and resolve issues.
• Participate in training, code reviews, and knowledge-sharing sessions to build expertise in validation, test automation, and regulated software development.
• Stay current with test automation tools, AI-assisted development practices, and evolving regulatory expectations (CSA, GxP, SaMD).

Minimum Requirements (Education and Experience)

• Education: BS in Computer Science, Software Engineering, Software Development, or a related field (recent graduates encouraged to apply).
• Experience: 0–2 years’ experience in software development or testing; relevant internships, co-ops, academic, capstone, or personal coding projects will be considered.

Required Knowledge, Skills and Abilities

• Solid programming fundamentals in at least one modern language such as JavaScript/TypeScript, Python, Java, or C#.
• A software development mindset: enjoys writing code, solving problems, and automating repetitive work.
• Familiarity with software testing concepts such as unit, integration, functional, and regression testing.
• Familiarity with version control (Git/Gitlab) and basic development workflows.
• Interest in or exposure to AI-assisted coding tools and a willingness to use them responsibly.
• Exposure to test automation frameworks (e.g., Selenium, Playwright, Cypress, Jest, PyTest, or similar) is a plus.
• Exposure to Salesforce (Apex, Lightning, Flows, or Trailhead coursework) is a plus but not required.
• Basic understanding of web technologies (HTML, CSS, REST APIs) and frontend/backend development principles.
• Strong attention to detail and the ability to document work clearly and accurately.
• Good written and verbal communication skills, and comfort asking questions and working in a team.
• Eagerness to learn software validation, GxP, and FDA medical device regulations; formal training will be provided.
• Interest in medical device, life sciences, or other regulated industries preferred.

Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

At Sequel, we believe that when you thrive, we thrive. That’s why our benefits package is designed to support you from day one. You’ll be automatically enrolled in our 401k plan, featuring a 6% company match and 100% immediate vesting. We’re committed to your well-being and understand the unique needs of employees and families living with diabetes, so we offer capped out-of-pocket insulin costs and GLP-1 coverage across all plans. You’ll have access to a variety of Meritain health insurance plans to suit your needs and can also take advantage of Flexible Spending Accounts (FSAs) or Health Savings Account (HSA). Our comprehensive benefits package includes vision and dental coverage, plus voluntary options such as long-term disability, accident, critical illness, hospital indemnity, and even discounts for pet care. In addition, we provide employer-paid short-term disability and life insurance for extra peace of mind.

We know the importance of taking time to rest and recharge. That’s why Sequel offers flexible PTO, generous paid holidays, and Flex Time options to help you balance work and life when you need it most. Our team enjoys a culture built on hard work, fun, and genuine support. At Sequel, you’re not just starting a job, you’re building a rewarding career and a brighter future. Join us, and let’s thrive together!

Environmental/Safety/Physical Work Conditions

Ensures environmental consciousness and safe practices are exhibited in decisions

Use of computer and telephone equipment and other related office accessories/devices to complete assignments

May work extended hours during peak business cycles

Physical requirements such as lifting specific weights

Some travelling is expected