Biomerics is a leading and innovative polymer solution provider to the medical device and biotech industries. We manufacture biomaterials, extrusions, injection molded components, and finished medical devices for many of the world's leading medical device corporations. We partner with our customers to increase their profitability through material technology, operational excellence, and premier market based customer service.
Project/Process Engineer for Technology Transfer
1605 Enterprise St.
75751 Athens , TX
Job Description: 

The Project/Process Engineer will be responsible for managing the execution of Technology Transfer and New Product Introduction (NPI) projects, regardless of scale, specifically focused on medical device technologies. These technologies include but are not limited to catheter based therapeutic and diagnostic instruments, urinary access devices, and occlusion removal systems. The Project/Process Engineer will work within the constraints of budget, schedule, and scope while managing risk and ensuring adherence to established processes and methodologies. The Project/Process Engineer will manage cross functional teams within assigned projects and will report to the Director of Technology Transfer.

Responsibilities Include: 
  • Interacting with customers, suppliers, and internal resources for medical device production
  • Demonstrating advanced knowledge of project and program management principals
  • Using project management tools to manage large and complex projects
  • Management of cross functional teams
  • Managing scope, time, and resources of large scale, complex projects
  • Facilitating identification of project or program risks, developing and assigning responsibility for mitigation actions, and managing the mitigation plan
  • Refining project management methodologies for quality and project or program risk management
  • Synthesizing critical information and communicating business implications to stakeholders
  • Contribute technical expertise to development of overall project and departmental strategies
  • Designing and development of tooling, equipment, and processes to facilitate the manufacture of medical devices
  • A Bachelor's degree in Engineering or related field required (Mechanical, Materials Science, Plastics, etc.) or equivalent work experience
  • A minimum of 3 to 5 years of experience required (work experience in the medical device or medical field is a plus)
  • The ability to lead a team toward operational objectives
  • Must be able to function with little supervision
  • A Six Sigma Green/Black Belt or ASQ CQE certification
  • The ability to perform statistical analysis using k-factors, PpK, and DOEs along with root cause analysis
  • Experience executing projects via a phase-gate analysis (Concept, Feasibility, Verification) using a risk-based approach (DFMEA) compliant with 21CFR/ISO-1497
  • Must understand design for manufacturability and assembly/ design for Six Sigma (DFMA/DFSS)
  • Must be able to author/co-author risk assessments & failure mode element analysis (RA/FMEA) per 1SO-14971
  • Must have experience with process validation, including:
    • Must be capable of validation definition and execution (IQ, OQ, PQ), test method definition, root cause analysis, Gage R&R, and measurement systems analysis (MSA)
    • Must be familiar with root cause analysis and structured problem solving
    • Experience and understanding of the development and design of plastic parts, blow molded parts, and assemblies
    • The ability to perform statistical analysis to ensure quality output of production processes
    • Must be a hands-on engineer who is comfortable rolling up their sleeves to develop and implement solutions
  • Must be self-motivated and thrives in a fast-paced and team-driven environment, where every day brings new projects and challenges