Senior Engineer II - Quality Design & Reliability Assurance

Integra LifeSciences seeks a Senior Engineer I to support medical device development within its quality organization. The role involves design assurance, risk analysis, and regulatory compliance across new product introduction and manufacturing transfers, requiring expertise in ISO standards and design control processes.

Responsibilities

• Lead design and development of medical devices collaborating with R&D and external partners
• Conduct and support risk analysis activities including FMEAs, SHAs, and design verification/validation
• Develop test plans, inspection methodologies, and acceptance criteria using statistical methods
• Support manufacturing transfers and contribute to root cause investigations and corrective actions
• Maintain quality system documentation and participate in internal and external audits

Requirements

• Bachelor's degree in engineering (electrical/electronic, mechanical, systems, or chemical preferred)
• 5+ years experience in medical device or regulated industry quality assurance roles
• Working knowledge of ISO 14971, 13485, EU MDR, FDA QSR, cGMP, and design control
• Proficiency with risk management tools, DFSS, statistical analysis, and process improvement methodologies
• Strong analytical and problem-solving skills with excellent written and verbal communication
• Proficient in MS Office Suite and statistical software; able to work independently with minimal supervision

Compensation: $71,000–$98,000 USD salary