SENIOR QUALITY ENGINEER

MedAcuity•Westford, MA

3d•$120,000 - $135,000•Hybrid

About The Position

MedAcuity, Inc. partners with product development companies to develop life- and mission-critical software, serving clients in medical devices, robotics, and aerospace and defense. The Senior Quality Engineer will contribute to software products and solutions in the MedTech space by defining test strategies, developing and coordinating verification and validation plans, driving quality analysis, and improving requirements for testability, gaps, and clarity. The role represents Quality Engineering on project teams and supports product quality throughout the product life cycle.

Requirements

At least 8 years of experience in quality testing.
Expertise with defect tracking and metrics.
Ability to design, develop, and implement test automation frameworks such as Pytest, Robot, TestComplete, or Squish.
Strong technical writing skills, including development of test methods, protocols, and reports.
Expertise with scripting languages such as Python.
At least 5 years of professional experience with GIT revision control and software development methodologies.
Understanding of Test Driven Development, Behavioral Driven Development, and data-driven test practices.
High adaptability and initiative.
Bachelor’s degree in Computer Science or a related discipline, or equivalent years of experience in a comparable role.

Nice To Haves

Knowledge of requirements management software such as Helix, ALM, or Jama.
Strong working knowledge of FDA QSRs, ISO 13485, IEC 62304, IEC 60601, and ISO 14971 requirements.
Experience with Agile and SCRUM methodologies.
Prior experience in a consulting capacity.

Responsibilities

Represent Quality Engineering as a core team member in activities such as verification and validation planning and risk analysis.
Contribute to process validation, design verification, and design validation, including input on statistical methods, test methodologies, test facilities, and test equipment.
Contribute to validation of software and/or production tools.
Develop and maintain Quality Plans throughout the product life cycle, beginning with project inception or initiation.
Develop and execute regression, acceptance, integration, performance, load, system-level, and reliability testing for systems and platforms.
Assist with issue resolution and failure investigations as required.
Conduct internal audits as assigned.
Maintain and comply with MedAcuity and client standard operating procedures.
Review procedures to ensure they are adequate for software and device development and conform to business and Quality Management System requirements.