Senior Validation Engineer

Sequel Med Tech, headquartered in Manchester, New Hampshire, is developing the next generation of transformative drug‑delivery advancements for diabetes management. Our flagship product, the twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type‑1 diabetes.

Sequel Med Tech is seeking a Senior Validation Engineer to support our growing portfolio of Enterprise systems. The Senior Validation Engineer is responsible for developing, executing, and maintaining validation deliverables to ensure compliance with regulatory requirements. This role focuses on ensuring systems and processes meet operational and regulatory standards. It involves collaboration with cross‑functional teams to support validation activities throughout the system lifecycle and serves as a subject‑matter expert to help our full‑stack engineers develop automated tests and review features for testing completeness.

The ideal candidate has experience with both manual and automated testing strategies and can communicate effectively with engineers, product leaders, and Quality stakeholders.

• Develop, execute, and maintain validation deliverables, including validation plans, specifications, protocols, summary reports, and SOPs.
• Conduct Computer System Validation (CSV) activities in compliance with FDA 21 CFR Part 11 and ISO guidelines.
• Perform and support risk assessments, gap analyses, and remediation for validation projects.
• Collaborate with cross‑functional teams to support change management processes and assess the impact on validated systems.
• Participate in internal and external audits and regulatory inspections, addressing validation‑related queries.
• Support lifecycle management of validated systems, including implementation, maintenance, and decommissioning.
• Contribute to the development and improvement of validation policies and procedures.
• Ensure the validation team is well‑trained and equipped to support GxP operations.
• Design and implement test cases for functional and automated testing, ensuring comprehensive coverage of requirements.
• Stay current with evolving regulatory expectations (CSA, GxP, SaMD) and technological advancements in validation and testing.
• Experience with Salesforce platform validation and integration would be ideal.

• BS in Computer Science, Software Engineering, or a related field, or equivalent professional experience.
• 6+ years’ experience in the software industry.
• Medical device or other regulated industry experience preferred.
• 3+ years’ experience with automated and technical verification.

• Ability to create and maintain validation deliverables such as validation plans, test plans, test cases, and test protocols.
• Effectively communicate the status and needs of the validation to engineers, product managers, and Quality partners.
• Broad experience with a range of test approaches and principles, with a general understanding of when and how to use different types of tests.
• Experience with Salesforce platform validation and integration would be ideal.
• Familiarity with validating or hands‑on experience with systems like Veeva Vault Quality Docs, Veeva QMS, ERP, CRM, AWS, Azure, Git Hub, Mule Soft or similar tools.
• Familiarity with frontend and backend development principles.
• Familiarity with CI/CD pipelines and Dev Sec Ops  processes.
• Experience with test case development, automated & functional testing according to requirements and test plans with attention to detail.
• Experience with test automation tools and frameworks.
• Ability to design, develop and maintain automated test suites.

Salary: $165,000 / yr – $195,000 / yr

Location:

Marlborough, MA

From day one you’re automatically enrolled in a 401(k) plan with a 6% company match and 100% immediate vesting. We prioritize your well‑being with capped out‑of‑pocket insulin costs and GLP‑1 coverage across all plans. Multiple medical plans are offered through Aetna, including a 100% company‑paid high‑deductible plan paired with employer HSA contributions. Additional benefits include vision and dental plans, employer‑paid short‑term disability, voluntary options like accident and pet insurance.

You’ll enjoy flexible PTO and generous paid holidays.

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.