Join Integra LifeSciences as a Senior Engineer II - Quality Design & Reliability Assurance and contribute to creating change and shaping the future of healthcare. The role requires expertise in medical device design and development, risk management, and quality systems.
Requirements
- Bachelor's degree in engineering (Electrical/Electronic preferred, others considered Mechanical, Systems, Chemical)
- 5 years of experience of working within a medical device or other regulated industry with knowledge of Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP.
- Strong analytical skills and a working knowledge of problem-solving methodologies
- Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques
- 5 years of experience in a Quality Assurance role for medical device or pharmaceutical product development
- Knowledge of industry best practices and advances in Risk Management practices, process, tools and technology
- Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
- Demonstrates excellent organizational, verbal and written communication skills
- Proficient with the MS Office Suite, and statistical software.
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- savings plan (401(k))
