Principal Quality Engineer

Medical Devices - Principal Quality Engineer - $150k - $190kBoston, MAUS Citizens or Green card holders onlyA clinical stage medical device company, pioneering the development of long-term therapy for patients with heart failure.The Principal Quality Engineer will play a pivotal role in investigating, planning, and implementing improvements in and/or additions to current products and manufacturing processes. You will implement a robust Quality Management System (QMS), oversee inspections, validation, and compliance with ISO 13485 and FDA regulations.Key ResponsibilitiesPerform inspections on components and subassemblies, ensuring compliance with approved specifications and procedures.Develop and implement processes to enhance product and process quality, including planning for product and service development, material control, acceptance activities, and measurement systems.Investigate and resolve non-conformities related to products, processes, and quality systems, providing updates to the executive team.Collaborate with suppliers to establish quality agreements, conduct audits, and develop control plans.Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.Support validation activities for new facilities, materials, equipment, and processes, including test method validations and clean room maintenance (Class 8 minimum).Coordinate sterilization validation and ensure compliance with cleanroom standards.Assist with regulatory submission documentation for IDE human clinical studies and ensure compliance with ISO 14971 Risk Management standards.Provide training and guidance to team members on quality management tools and practices, promoting awareness of the Quality System throughout the organization.Participate in external audits and develop responses to queries during and after audits.RequirementsBachelor's degree (or higher) in Biomedical Engineering or a related field, with 8+ years of experience in medical device development or quality assurance.A minimum of 5 years' experience in a Class II or III medical device environment; experience with ventricular assist devices is highly desirable.Expertise in electrical and mechanical systems for medical devices in regulated environments.Strong knowledge of design control requirements, verification, and validation processes.Working knowledge of quality systems, risk management tools, and standards, such as FMEA, ISO 14708, ISO 17025, ISO 14971, ISO 13485, and 21 CFR Part 820, 803, and 806.Experience across all product lifecycle phases, from conception to commercialization, in a Design Assurance role.Proficiency in Microsoft Office, with experience in project planning software and DAQ systems. Familiarity with MATLAB is a plus.Professional certifications from the American Society for Quality (e.g., CQE, CRE, CSQE, or CBA) are desirable.

Created: 2025-01-29