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Senior Biomechanical Engineer Onsite

2 months ago

Leesburg, United States Ledgent Technology Full time

Senior Biomechanical Engineer - Onsite

Pay Rate Range: $60.00/hr. - $80.00/hr.

Description/Comment:

Apply knowledge of engineering, biology, and biomechanical principles to the design, development, and evaluation of biological and health systems and products, such as artificial organs, prostheses, instrumentation, medical information systems, and health management and care delivery systems. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree, or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years' experience.

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 Client 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.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. To the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.