Company:

This client has been a leader in the field of regenerative medicine and medical devices for over 30 years, providing solutions from organ procurement to new innovations in bio-implant technologies and cellular therapies. As they continue to grow, it is essential that they continue to also focus on bringing in talented people they can grow within the company for years to come. This particular role will play a vital role in the company’s continued success, responsible for helping to design, development and/or implement clinical solutions and manufacturing processes including improvements to existing products and processes. This is an excellent landing spot for someone who is looking for an opportunity to grow their career, not just their next job.  

 

Job Summary:

This individual will be responsible for helping to design, development and/or implement allograft clinical solutions and manufacturing processes including improvements to existing products and processes.

 

Primary Duties: 

  • Under supervision, designs and develops new or improved allograft tissue products, equipment and processes under the supervision of a senior engineer or manager.
  • Serves as the lead engineering resource and/or the project lead on projects using existing technology or as an engineering resource on new technology projects. This includes responsibility to investigate assigned complaints and errors.
  • Drafts and coordinates the execution of testing protocols of new allograft tissues, new processes and the improvement of existing processes. Generates technical protocols and reports as applies to verification and validation of new products and/or improvement implementations.
  • Responsible for growing knowledge base and training peers on new or existing procedures and acts as a Subject Matter Expert (lead to be consulted with on proposed changes, improvements, etc.) for new or existing equipment, processes or products.
  • Maintains production, design and development records in accordance with Standard Operating Procedures (SOPs).
  • Supports the engineering needs of other departments as determined appropriate.
  • Recommend improved processes, procedures, equipment, and materials which will enhance the efficiency of manufacture and quality of company's products.
  • Develop and conduct employee training sessions as needed for new equipment and process.
  • Assist R&D in the development and scale-up of new products.              
  • Develop, implement and communicate, work instructions, procedures and other documentation as necessary to support work responsibilities.     
  • Perform other duties as may be assigned. 

 

Requirements:

  • 5+ years of experience in a similar role.

  • Minimum B.S. Engineering with concentration in Mechanical, Industrial, Biomedical, or Chemical curriculum, plus documented Engineering experience in a manufacturing environment.

  • Good communication skills, project scheduling and small team leadership abilities.

  • Ability to multi-task in a fast paced environment.

  • Excellent PC and software user skills required.

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