Sr. R&D Engineer

Company Overview

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.

Position Overview:

Leverage extensive knowledge and experience of material science and engineering design to advance the development of advanced medical devices in the structural heart and vascular space. Identify and develop next generation and disruptive technologies through partnerships and collaboration with clinicians and external and internal partners.

Delineate in vitro and in vivo test plans to allow for development of new medical devices. Modify current product designs and processes to improve manufacturability, reliability, and resolve manufacturing challenges through collaboration with internal and external partners. Create formal documentation and coordinate/execute testing to characterize and qualify concepts, products, and methods.

Foster and mentor the advancement of junior research engineers throughout the stages of new product development. Exercise knowledge of Design Control and New Product Development processes to deliver on project milestones.

Position Responsibilities:

1. Investigate and evaluate technologies for future generation of medical devices. This includes:
   1. Design, fabrication, and testing of prototypes
   2. Consulting with physician users to optimize and select between potential designs
   3. Present recommendations to senior management
2. Develop intellectual property IP
3. Development and execution of test plans for design verification and validation
4. Create 3D models and engineering drawings for products as well as any tools and fixtures
5. Serve as technical project lead for projects
6. Development of an in-depth knowledge of medical device technologies including IP, competitive landscape, current technologies, and future developments.
7. Successful commercialization of R&D new product development efforts
8. Work with outside OEM Suppliers, internal/external machine shops and or other departments/groups
9. Design and implement custom equipment/ tools, fixtures and/or off the shelf equipment/ tools, fixtures for highly capable manufacturing processes for new and existing products through frequent interaction with R&D, Manufacturing Engineering, Quality Engineering, and Operations.

Qualifications (Required):

1. BS Degree in Mechanical Engineering or Biomedical Engineering; MS in an Engineering, Math, or Science discipline also preferred
2. 5 years of relevant work experience in medical device design and development of implantable devices, preferably endovascular stent grafts and catheter based delivery systems
3. Knowledge in materials associated with medical devices such as polymers (nylons, polyethylene, polypropylene, PEEK, Pebax, PTFE, FEP, polycarbonate, etc.) metals (stainless steel, aluminum, nitinol, platinum etc.), ceramic, fiber, composites, etc.
4. Knowledge in processes associated with medical device manufacturing such as shrinking (reflow), RF welding, laser/thermal/adhesive/solvent bonding, welding & cutting, braiding, coil winding, insert molding, hydrophilic coating, injection molding, extrusion, pad printing, laser marking, tray sealing, manual assembly, automated assembly, etc.
5. Knowledge and experience with New Product Development and Design Controls
6. Knowledge and experience of mechanical testing, biomaterials, devices, and tissue biomechanical testing and developing and procuring conceptual and functional prototypes
7. Exemplary verbal, technical, and written communication skills
8. Experience creating 3D CAD models and 2D engineering drawings; must be a proficient user of SolidWorks; must be familiar with ASME Yl4.5-2009
9. Experience authoring Design Verification and Design Validation protocols and reports, and coordinating or performing the execution of those studies
10. Experience performing and documenting FMEAs and risk management activities

Qualifications (Desired):

1. Experience developing in vitro, in situ, in vivo, and ex vivo mechanical, thermal, and/or biomechanical tests and experiments with cardiovascular medical devices
2. Experience developing and testing class III cardiovascular medical devices
3. Project management experience including timeline and budget management, presenting to executive management, minimizing project risk, and documentation creation and organization
4. Statistical data analysis, Minitab knowledge preferred
5. Experience developing, authoring, or improving Quality System procedures and practices is preferred
6. Knowledge of common medical device standards such as ISO 62366, ISO 10993, ANSI HE75, ISO 11607, IEC 60601, ISO 15223, etc.
7. Experience preparing and submitting regulatory documents to the FDA and other notified bodies