FAQ
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.
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Principal R&D Engineer
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| City: Plymouth
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Relocation Available: No |
| State/Province: MN
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| Country: United States |
Type (Duration): Regular, Full Time
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| Job Number: 1576 |
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| Functional Area: Research & Development
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| Division: Research & Development |
Work Hours: Standard |
As a Principal R&D Engineer, you will provide technical engineering to lead product development and transfer of innovative, minimally invasive medical products from research through manufacturing including the design, development, testing and documentation in accordance with design control procedures.
The primary role is within the product development process, representing the R&D function. In this role you will lead development efforts to generate the necessary documentation and data to convey design intent and support submission of these devices to regulatory agencies for approval.
- Design and develop new interventional medical devices following design control procedures
- Construct and evaluate prototype medical devices
- Generate the necessary documentation to convey design intent – including drawings, material specifications, protocols and reports
- Maintain a detailed laboratory notebook
- Translate design inputs into engineering specifications
- Identify and establish relationships with key suppliers for research and development and production components
- Create detailed design risk analysis reports
- Perform design verification and validation testing
- Prepare time lines, cost analyses and resource needs
- Lead project teams
- Perform all job functions in accordance with applicable AGA, FDA, and ISO standards
Qualifications:
- BS in Engineering or related area
- Eight plus years of medical device R&D experience
- Good written and verbal communication, record keeping and technical documentation
- Demonstrated problem solving and decision making skills
- Demonstrated creativity and "hands on" prototyping skills
- Working knowledge of ISO, GMP, and FDA experience is a plus
- Computer proficiency with Microsoft applications
- FEA and Minitab knowledge desired
- Ability to work independently and take initiative
- Experience with cross-functional team based Product development
- Experience with machine shop, extrusion, braiding, or laser weld desired
- Design experience with nitinol a plus
- Supervisory experience a plus
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Submit Application
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We offer an excellent compensation and benefits package including medical, dental, life insurance, disability, 401(k), and much more.
An Equal Opportunity / Affirmative Action Employer
Please, No Agencies.
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Contact Us
AGA Medical Corporation
5050 Nathan Lane North
Plymouth, MN 55442
USA
Toll Free: 1-888-546-4407
Phone: 1-763-513-9227
Fax: 1-763-513-9226
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