About This Role Veranex has an exciting opportunity to join our team as a Senior Design Assurance Engineer. You will be part of a team working to improve lives globally through medical technology innovation. The Design Assurance Engineer is responsible for accurate, independent generation and evaluation of risk management, design history file documentation and overall quality system compliance. Ensures compliance to customer and regulatory requirements and assists with the successful transfer of design to manufacturing. Plans and leads execution of risk management on cross-functional product development teams.
What You Will Do- Lead risk management for novel and existing medical devices, including risk management plans and reports, hazard analyses and use, design, and process Failure Mode & Effects Analysis (FMEA).
- Plans, develops, and executes verification and validation testing for products under development.
- Provides input to development teams in the design of highly complex medical devices (including electrical, mechanical, software, drug, IVD). Provides quality insight and leadership on program teams and assists with establishing appropriate build quality controls appropriate with use.
- Develops, documents, and validates inspection and test methods to support development and manufacturing.
- Participate in the technical review of design input specifications and design documentation for new medical devices.
- Assists with implementing and maintaining a quality system that is compliant with relevant quality system regulation requirements. Participate in Quality System continuous improvement activities.
- Ensures the successful integration of quality assurance and regulatory compliance, working across multiple teams and medical device/equipment categories.
- Supports internal and external audit activities.
- Trains and mentors new and less experienced engineers. May provide performance feedback on performance of peers to functional management.
Required Qualifications- Bachelor's degree in engineering or related field
- 3-6 years of relevant work experience in medical devices, or an equivalent combination of education, experience and training
- Working understanding of ISO 13483 and ISO 14971.
- Has experience in ISO10993, IEC60601, IEC62304, IEC62366, MDR and IVDR.
- Working understanding of Food & Drug Administration (FDA) Quality System regulations, European Active Implantable & Medical Device Regulations, and relevant medical device principles
- Excellent written and oral communication skills
- Excellent attention to detail
Preferred Qualifications - Demonstrated experience with client management
- Experience with different quality management systems
Location- This is an onsite position in Minneapolis, MN
