Biomerics FMI, LLC
Biomerics is a world class contract manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in the design, development, and production of medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for the vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.Please explore our website for more information about our offerings and capabilities.
Project Engineer for Technology Transfer
Full-time
Biomerics FMI, LLC
Biomerics FMI, LLC
1605 Enterprise
75751 Athens , TX
Job Description: 

The candidate 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 candidate will work within the constraints of budget, schedule, and scope while managing risk and ensuring adherence to established processes and methodologies. The candidate 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.
Education/Experience: 
  • A Bachelor's degree in related field required (Mechanical, Materials Science, Plastics, etc.) 
  • A minimum of 8 years of experience required, 5+ years of related work experience in the medical field
Special Skills/Abilities/Knowledge: 
  • The ability to lead a team toward operational objectives. (Required)
  • Must have experience working through all aspects of medical device process validation/ technology transfer. (Required)
  • Must be able to function with little supervision. (Required)
  • Experience in the field of PTA and/or other Balloon Catheter Markets. (Preferred)
  • A Six Sigma Green/Black Belt or ASQ CQE certification. (Preferred)
  • The ability to perform statistical analysis using k-factors, Ppk, and DOEs along with root cause analysis. (Required)
  • Experience executing projects via a phase-gate analysis (Concept, Feasibility, Verification) using a risk-based approach (DFMEA) compliant with 21CFR/ISO-1497. (Preferred)
  • Must be proficient in solid 3-D modeling using SolidWorks. (Required)
  • Must understand design for manufacturability and assembly/design for six sigma (DFMA/DFSS). (Required)
  • Must be able to author/co-author risk assessments & failure mode element analysis (RA/FMEA) per 1SO-14971. (Preferred)

Must have experience with medical 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). (Required)
  • Must be familiar with root cause analysis and structured problem solving. (Required)
  • Experience and understanding of the development and design of plastic parts, blow molded parts, and assemblies. (Preferred)
  • The ability to perform statistical analysis to ensure quality output of production processes. (Preferred)
  • Must be a hands-on engineer who is comfortable rolling up their sleeves to develop and implement solutions. (Preferred)
  • Must be self-motivated and thrives in a fast –paced and team-driven environment, where every day brings new projects and challenges. (Preferred)