Sr. Engineer, Biomechanical Engineering

1 week ago

Leesburg, United States IntePros Full time
Compensation Range:

$55/hr

Welcome to IntePros, a certified woman-owned company specializing in innovative and results-oriented recruiting and staffing solutions. We take immense pride in genuinely understanding what drives and inspires exceptional individuals like you. Your success is our priority, and we are dedicated to actively shaping your long-term career journey. At IntePros, we believe in comprehensive well-being. You have access to our medical, dental, vision, and mental health programs, ensuring your health and wellness are taken care of. To support your continuous growth, we also provide a $1,500 per year education and professional certification fund. Diversity and inclusion are cornerstones of our company ethos. IntePros is proud to be an equal opportunity employer. We do not discriminate in employment on the basis of race, color, religion, sex, pregnancy, gender identity, national origin, sexual orientation, disability, age, veteran or military status, retaliation, or any other characteristic protected by law. We celebrate the rich tapestry of backgrounds and perspectives that make us stronger as a team. Please note that only qualified individuals being considered will be contacted. We appreciate your interest and look forward to potentially embarking on a transformative journey together.

Our client, a large Medical Device company is looking for a Laser Marking SME within their Spine Division.

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 Stryker 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.



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