Overview
EU MDR Project support for creation of technical documentation, test reports, etc. for medical devices. The products will include implantable devices and instruments. This position will be part of an R&D team focused on EU MDR compliance. This individual will be considered as a laser marking SME & will be responsible for developing the AIDC path forward for the Spine Division as a member of the EU MDR team.
Must have requirements for this position include:
- Ability to define the project scope by evaluating product characteristics (i.e., materials, coatings, dimensional, region limitations, PREN, etc.) and supplier capabilities; identify worst-case materials & parts.
- Ability to use Mechanical engineering knowledge/skills to do a deep-dive review of other Divisions’ capability studies and other testing for synergies.
- Ability to use Mechanical engineering knowledge/skills and technical writing skills for creation of Engineering Analysis documents.
- Ability to interface closely with our test lab to develop and execute capability studies. General test constructs discussed include the following (but not limited to):
- Determine robustness of AIDC 2D barcode on various materials over a fixed period/re-use; determine the timeframe that the barcode on the part is readable/durable over product lifetime; determine limitations on geometry/material/surface finishes.
- Ability to partner with Sourcing Team to initiate conversations with suppliers on their AIDC 2D barcode capabilities.
- Ability to research the appropriate AIDC 2D barcode reader required to comply with ISO29158 & Minimum Grade C standards.
Prefer to have requirements for this position include:
- Ability to work closely with design teams & suppliers by managing the process and the development of new laser marking solutions through the full life cycle, including conceptual design, process development, and continuous improvement.
- Ability to function as a Project Manager to coordinate all activities between the Spine Division and other company Divisions such as Trama and Extremities, Joint Replacement, etc.
- Ability to further coordinate with Project Management, Sourcing, Manufacturing, Sourcing, Engineering/AO/GQO, regarding potential risk for subsequent development activities.
All work will be done using Teams/SharePoint style collaboration sites. Attention to detail and application of sound engineering practices is very important to ensure compliance of regulations to meet the EUMDR compliance standards. This job typically requires a degree or equivalent and a minimum of 10, or more years’ experience.