Participates in all aspects of product, process, and supplier development in order to ensure the highest level of quality in new products, and their compliance to applicable regulations and standards.
- Represent Quality Engineering on cross-functional teams, interfacing among multiple departments and teams such as Manufacturing, R&D, Regulatory Affairs, Operations/Planning, and Marketing.
- Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts.
- Review and approve change orders on assigned projects and product lines.
- Plan, design, and implement test methods, including test equipment, for inspection of product.
- Evaluate, update, and improve difficult manufacturing processes and engineering systems for assigned product lines.
- Work with suppliers to continually improve technical processes, reliability, and inspections to meet Inari’s quality standards.
- Participates in drafting and implementing risk analysis documentation for new products with identified hazards and harms.
- Provide leadership and guidance, in the scope of quality systems, to ensure compliance within designated projects and product lines.
- Apply statistical rationale to plan, analyze, and interpret engineering test data collected during new testing.
- Performs special projects as assigned.
- Bachelor’s degree in Engineering (mechanical, biomedical, or materials preferred).
- Broad knowledge of applicable regulations and standards, e.g. QSR, ISO 13485.
- Good knowledge of Design Controls and Risk Management for medical devices.
- Working knowledge of data collection, data analysis/evaluation, and scientific method.
- Minimum 5 years’ experience in a quality engineering role.
- Excellent, proven interpersonal, verbal and written communication skills.
- Critical thinking skills and good judgment.