Senior Manufacturing Quality Engineer - $115k - $135k

US Citizen and Green card holders only

This role focuses on quality assurance for the production, testing, and distribution of a next-generation Total Artificial Heart (TAH) system, working closely with senior leadership to establish manufacturing standards, quality systems, and regulatory compliance.

Key Responsibilities:

• Enhance manufacturing processes to meet quality standards, ensuring compliance with ISO 13485, 21 CFR 820, and related regulations.
• Identify process improvement opportunities; implement robust inspection and testing methods.
• Analyze manufacturing data to improve product reliability and production efficiency.
• Conduct and document inspections of materials, components, and finished goods.
• Collaborate with cross-functional engineering teams to support and optimize manufacturing processes.
• Provide training on quality management systems and tools.
• Develop, validate, and execute test methods aligned with user needs and design specifications.
• Support risk management activities, including FMEA updates and compliance with ISO 14971.
• Collaborate with suppliers on quality agreements, audits, and performance standards.
• Manage complaint investigations, CAPA processes, and failure analyses, reporting progress to leadership.
• Prepare documentation for regulatory submissions and maintain cleanroom standards (Class 8 minimum).
• Participate in audits, addressing findings and implementing corrective actions.

Qualifications:

• Bachelor’s degree in Biomedical Engineering or a related field.
• 8+ years of experience in quality assurance or manufacturing within the medical device industry, including 5+ years with Class II or III devices.
• Deep knowledge of quality systems, design controls, risk management, and standards (ISO 13485, ISO 14971, etc.).
• Expertise in statistical analysis, reliability engineering, and quality improvement tools.
• Proficiency with FMEA, DAQ systems, and project management tools; MATLAB experience is a plus.
• Experience with electrical and mechanical systems in a regulated environment.
• Preferred certifications: CQE, CRE, CSQE, or CBA.
• Strong problem-solving and organizational skills; ability to work independently.

Preferred Experience:

• Background in ventricular assist devices or similar medical systems.
• Hands-on experience across the product lifecycle, from concept to commercialization.