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AGA Medical Corporation is dedicated to the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.
Our Mission
AGA Medical Corporation is dedicated to the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.
History and Future
AGA Medical Corporation is a privately-held medical technology company headquartered in Plymouth, Minnesota.
Learn More about AGA Medical
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AGA Medical Corporation, a medical technology company, is dedicated to the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.
As a Senior Design Assurance Engineer, you will have two key roles. You will be the key driver in assuring that our products meet the needs of the customer as you work as a core team member in partnership with a Product Development team. In addition, you will be the Lead for packaging design and development across multiple product development teams.
Specific Design Assurance project activities include:
- Work with the team to identify appropriate customer requirements for the product.
- Work with the team to identify product specifications that correctly define the product.
- Define the risk management approach.
- Facilitate product risk analysis from a design and process perspective.
- Provide insight and direction to appropriate inspection of materials.
- Define with the team appropriate testing and develop the test plans.
- Analyze testing results and confirm that our products meet the requirements set forth.
- Provide clear concise documented evidence of the quality of our product to regulatory bodies.
- Provide scope, deliverables planning, and timelines to the project for planning and subsequent management of product assurance deliverables to meet project timelines.
Specific Packaging project activities include:
Work with the product development team to identify packaging specifications.
- Develop packaging concepts.
- Work with external vendors to develop packaging concepts.
- Define testing requirements and facilitate testing.
- Create plans and reports.
Additional activities include:
- Assist in the development of QA/QC policies and procedure to ensure department efficiency and compliance to appropriate regulations.
- Conduct training as needed on design assurance methodology, concepts and tools.
- Support the quality objectives of other engineering disciplines within product development as needed.
Qaualifications:
- BS degree in Engineering or related field.
- Preferred work experience of 5-7 years in Product(Design) Assurance Engineering.
- Preferred experience of at least 2 years in conducting product risk analysis.
- Knowledge and application of QSR, ISO and other applicable international regulations.
- Knowledge and application of mechanical measurement systems, measurement techniques and process capability studies.
- Ability to read mechanical drawings, understand geometric dimensioning & tolerancing and design appropriate inspection methods to ensure design intent is maintained.
- Ability to interact effectively with a cross-function team.
- Ability to facilitate meetings.
- Computer efficiency in Microsoft programs relevant to job responsibilities.
- Ability to constructively interact with a range of personalities at many levels of the organization.
- Experience in medical device industry preferred.
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