Design Assurance Engineer needed in Plymouth, MN!
This role is a unique opportunity to be involved in the development of products and process for medical components through finished medical devices. This person will be directly involved in tasks to support product development that involves direct communication with suppliers, customers and team members. This person must be able to use their expertise to work quickly to solve problems.
In addition to the above, this person:
1. Adheres to Integer values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
2. Is the quality department Core Team member where they perform engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled according to their procedures. This person builds consensus where appropriate.
3. Leads Risk Management (ISO 14971) activities which includes a cross functional team for the planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations for each product or process. Maintains risk management file for the life of the products they are responsible for.
4. Generates and/or reviews related project deliverables such as: design verification and design validation protocols and reports as well as process verification and process validation protocols and reports. This person will coordinate these with the R&D team in the review of technical documentation.
5. Works with Product Development Engineering teams in the development and qualification of test methods including fixture, acceptance criteria and test methodology development.
6. Coordinates sourced item qualification activities and supports supplier risk management initiatives. Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determine
Education & Experience:
Minimum Education: Bachelor’s Degree in Engineering or related field required. Master’s Degree preferred.
Minimum Experience: 5-7 years of experience.
Knowledge & Skills