Growing & Profitable $4B Medical Device Manufacturer seeking talented Senior Design Assurance Engineer for one of their large manufacturing sites. This position will be responsible for working with New Product Introductions for one of their division. This is a senior role, looking for some with experience in doing this for another company. Great work environment! Come be a part of a strong, intellectually curious learning team that supports New Productions Introduction.
Opportunities for growth!
- BS degree in Technical degree (engineering, sciences, etc.)
- Must have 5+ years of design quality assurance (working on NPI) in a FDA regulated industry, preferably Medical Device Manufacturing. (must understand risk management, design control process and product development process)
- R&D Engineering or Quality Engineering Experience is a plus
- Must have strong knowledge of FDA Quality System Regulations, ISO 13485, etc.
- Working knowledge of ISO 14971, risk evaluation techniques, FMEA, fault tree analysis or HACCP
- Must have experience with reliability analysis, test methods, and test method validation
- Working knowledge of IEC60601, IEC62366, EN62304
- Must be skilled in test plan development and root cause failure analysis and working knowledge of supplier quality management.
- Strong verbal and written communication skills especially technical report writing.
- Must excel at strong collaboration, and working with cross functional teams (project teams), including taking leadership role in critical tasks to assure appropriate and timely completion/resolution
- Ability to appropriately assess written design and device documentation as the principle advocate for compliance