Biomerics FMI, LLC
Biomerics is a leading full-service medical device contract manufacturer providing material and process technology for the interventional cardiology, interventional radiology, vascular access, and advanced surgical device markets. Biomerics is headquartered in Salt Lake City, UT with operations in UT, MN, TX and Costa Rica. Biomerics is a privately owned, rapidly growing company requiring highly motivated, hard-working professionals to support the growth.
Director of Development of Balloon Catheters
Full-time
Biomerics FMI, LLC
Biomerics FMI, LLC
1605 Enterprise St.
75751 Athens , TX
Job Description: 

The Director of Development of Balloon Catheters is responsible for managing the execution of New Product Development (NPD) and New Product Introduction (NPI) projects, regardless of scale, and will manage project leaders within assigned projects.  The person in this position will work within the constraints of budget, schedule, and scope while managing risk and ensuring adherence to established processes and methodologies.  This position reports to the VP of Engineering in Athens, Texas.

Responsibilities Include: 
  • Interacting with customers, suppliers, and internal resources
  • Demonstrating advanced knowledge of project and program management principals
  • Using project management tools to manage large and complex projects or programs
  • Management of Technology Transfer 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
  • Synthesizing critical information and communicating business implications to stakeholders
  • Other duties as assigned
Education/Experience: 
  • A Bachelor’s degree in related field required (Mechanical, Materials Science, Plastics, etc.).
  • A minimum of 8+years of related work experience in the medical device field
  • The ability to lead a team toward operational objectives with aptitude to contribute to strategic goal-setting for department/business unit
  • Must have experience working through all aspects of medical device design/development including process validation/technology transfer
  • Must be able to function with little or no supervision
  • The ability to perform statistical analysis using k-factors, Ppk, and DOEs along with root cause analysis
  • Successful candidate must be eligible to work in the United States. 
Special Skills/Abilities/Knowledge: 
  • The ability to perform statistical analysis using k-factors, Ppk, and DOEs along with root cause analysis
  • 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:
    • Subject matter expert in a directly applicable sub-field (e.g. balloon forming, injection molding, extrusion, electro-mechanical, etc. preferred
    • Must be proficient in solid 3-D modeling (i.e. SolidWorks 2010-2013)
    • Must understand design for manufacturability and assembly/design for Six Sigma (DFMA/DFSS) preferred
    • Ability to author/co-author risk assessments and failure mode element analysis (PFMEA) per ISO-14971 preferred
  • Experience with medical process validations including:
    • Capable of supporting 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 design for plastics injection-mold fabrication processes
    • Experience and understanding of the development and design of plastic parts, insert molded parts, and assemblies
    • The ability to conduct design review(s) of hot/cold runner injection molds
    • Experience and understanding of the design for profile extrusion processes
    • Experience and understanding of the development and design of single, co-extruded components
    • The ability to establish the parameters for an optimal molding environment
    • The Six Sigma Green/Black Belt or ASQ CQE certification is preferred
Work Environment: 

Physical Requirements

The person in this position needs to be able to stay in a stationary position 50% of the time throughout the workday.  Other times, the person is required to be on the production floor assessing procedures, processes and reviewing alternate solutions to production floor challenges. 

This position is required to detect/perceive/inspect with or without visual aids such as contacts or eye glasses. The person in this position is required to operate a computer, office equipment, and production floor machinery throughout the day.  Reasonable accommodation may be available.  Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

 

Work Environment

The employee will frequently have minimal exposure to the manufacturing environment (i.e. noise, minimal heat, and some chemical fumes).  Requires working in close, physical proximity to other workers.  Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.  Includes sitting and working in close proximity to other employees.  Low to mid-level noise.  Controlled temperature, florescent lights, phone conversations, occasional overhead paging.  Reasonable accommodation available.

 

 

To apply for this position, please send your cover letter and resume to tclark@biomerics.com or

fax to the attention of T. Clark at (903) 677-9168.