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.
Director of Medical Balloon Center of Excellence
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 New Product Development (NPD) and New Product Introduction (NPI) projects, regardless of scale, specifically focused on medical balloon technologies. These technologies include new and innovative indications using compliant, semicompliant, and non-compliant materials including Urethanes, Nylons, Peba, and PET. 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 project leaders within assigned projects and will report to the VP of Engineering.

Responsibilities Include: 
  • Interacting with customers, suppliers, and internal resources for medical balloons. 
  • Demonstrating advanced knowledge of project and program management principals. 
  • Using project management tools to manage large and complex projects or programs. 
  • Management of Project Engineering Staff. 
  • Defining and managing scope, time, and resources of large scale, complex projects or programs. 
  • 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.
Education/Experience: 

A Bachelor's degree in related field required (Mechanical, Materials Science, Plastics, etc. (Preferred). A minimum of 5 years experience required, 10+ years of related work experience in the medical balloon field Preferred.

Special Skills/Abilities/Knowledge: 

The ability to lead a team toward operational objectives with aptitude to contribute to strategic goal-setting for department/business unit (Required).
Must have experience working through all aspects of medical balloon design/development including design V&V and process validation/ technology transfer (Required).
Must be able to function with little or no 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 developing designs and testing via a phase-gate analysis (Concept, Feasibility, Verification) using a risk-based approach (dFMEA) compliant with 21CFR/ISO-14971, including:

  • Must be a subject matter expert in a directly applicable sub-field (e.g. balloon forming, balloon catheter, ect.) (Preferred).o Must be proficient in solid 3-D modeling (i.e. SolidWorks 2010-2013) (Preferred).
  • Must understand design for manufacturability and assembly/ design for six sigma (DFMA/DFSS) (Preferred).
  • 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 supporting 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 design for medical balloon fabrication processes (Required).
  • Experience and understanding of the development and design of plastic parts, blow molded parts, and assemblies (Preferred).
  • The ability to conduct design review(s) of balloon tooling and systems. (Required).
  • Experience and understanding of the design for profile balloon forming processes (Preferred).
  • The ability to perform statistical analysis to ensure quality output of blow molded medical balloon components (Preferred).
  • The ability to establish the parameters for an optimal molding environment (Required).