Support testing and quality assurance processes for the Affera Mapping and Ablation System, ensuring reliability and performance of advanced medical devices.
Locations (2)
Mounds View, Minnesota, United States
Newton, Massachusetts, United States
Compensation
Salary ranges for U.S (excl. PR) locations (USD):$67,200.00 - $100,800.00
Responsibilities
Test the functionality and performance of the systems software
Develop and execute manual test plans and scripts designed to detect problems
Maintain broad understanding of current testing software technologies
Ensure systems software meets technical and functional requirements
Perform workflow analysis, document test results and recommend quality improvements
Lead cross‑functional technical teams or workstreams for product development, platform development, and life‑cycle management of prefilled syringe (PFS) platform technologies used in combination products.
Compensation
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Responsibilities
Lead assigned cross‑functional technical teams or workstreams for product development, platform development, and life‑cycle management initiatives; align contributors on scope, technical deliverables, decisions, and milestones.
Develop and maintain technical work plans, schedules, dependencies, risks, and action tracking; communicate status and escalate issues that could affect scope, quality, or milestones.
Contribute to PFS platform development and life‑cycle management activities, including design inputs, design outputs, verification, characterization, aging, and design transfer.
Plan and execute engineering tests for devices, primary containers, and packaging using approved protocols, procedures, and sampling approaches; document results and escalate unexpected outcomes.
Draft and revise protocols, reports, requirements, risk assessments, technical rationales, and other design‑control records in applicable document and laboratory systems.
The Senior Product Owner - CSV is responsible for leading and managing Computer System Validation (CSV) activities to ensure digital systems are compliant, validated, and fit for purpose throughout their lifecycle. The role works closely with business, quality, validation, and technology teams to translate business and regulatory requirements into compliant solutions, validation strategies, and prioritized deliverables.
Responsibilities
Manage CSV requirements, validation deliverables, and compliance activities for MES systems.
Own and manage CSV requirements, validation activities, risk assessments, testing, change controls, and release readiness to ensure 100% compliance with GxP, data integrity, security, and regulatory requirements.
Ensure on-time delivery of validation documentation, test evidence, and approvals, maintain systems in a validated and audit-ready state throughout their lifecycle.
Drive audit and inspection readiness, minimizing compliance observations and ensuring timely closure of audit findings, deviations, CAPAs, and change controls.
Collaborate with business, quality, engineering, and site teams to deliver validated solutions that meet business objectives and regulatory expectations.
Requirements
Bachelor’s or master’s degree in computer science, Information Technology, Engineering, Business, Life Sciences or a related discipline
Hardware Test Engineer in R&D team responsible for planning, developing, and executing verification and validation tests for laboratory instruments and automation systems.
Responsibilities
Translate hardware and system requirements into test strategies, protocols, acceptance criteria, and traceable test cases.
Develop and execute verification tests for instrument hardware, electromechanical assemblies, and automation systems.
Create or improve test fixtures, measurement setups, and automated test tools.
Coordinate with design engineers to confirm testability, review test methods, and resolve gaps between requirements and test coverage.
Analyze test results, investigate failures, document defects, and work with engineering teams to identify root causes and verify corrective actions.
Requirements
Bachelor’s degree in engineering, computer science, chemistry, bioengineering, biomedical laboratory science, or a related technical field
Nice to have: testing laboratory instruments
Nice to have: analytical equipment
Nice to have: automation systems
Nice to have: regulated product-development environment
Validation Lead for CoreAI Lab Instrument Integration, responsible for CSV and CSA strategy for integrating analytical and quality control laboratory instruments into the Tetra Data Platform.
Compensation
Pay Rate Range: $58.33 - 62.12/hr.
Responsibilities
Formulate and execute a validation strategy for laboratory instrument integration via the Tetra Data Platform, ensuring alignment with GAMP 5, Roche Quality Management Standards, and global health authority regulations (FDA, EMA, Swissmedic).
Author and execute validation master plans (VMP), user requirements specifications (URS), risk assessments, and qualification protocols (IQ/OQ/PQ) for Tetra Data Hubs, Tetra Agents, cloud connectors, and raw-to-IDS parsing pipelines.
Enforce ALCOA+ data integrity principles and 21 CFR Part 11 / EU Annex 11 compliance across all instrument data streams. Qualify automated audit trail capture, electronic signatures, and bidirectional metadata flows between instruments and Level 3 systems (LIMS, ELN, LES).
Lead end-to-end verification and boundary testing alongside dedicated testers and QA. Drive the adoption of automated test scripts within CI/CD pipelines to validate data ingestion schemas and reduce manual regression testing.
Collaborate closely with Analytical Development scientists, QC lab leads, IT/OT engineers, and cloud platform architects to define scope and acceptance criteria. Partner with vendors (TetraScience, analytical instrument OEMs) to review vendor documentation and establish supplier quality assessments.
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