Senior Manufacturing Engineer, Medical Device

Houston, Texas | Engineering

Sr. Manufacturing Engineer

 

Organic growth of +10% per year in a small to medium sized company is the definition of exciting. You are constantly testing your limits and seeing how your contributions impact the business.  It’s an opportunity to learn every cog in the business wheel and know that at some point, that experience will be invaluable.  

 

What do you need to bring?  The challenge of this position is that your skills in Medical Device Manufacturing, Validation (from protocol writing to implementation), designing and building of electrical test equipment and the planning, scheduling and completion of projects all have an equally important role. Your background might be strong in Manufacturing Engineering/Validation, or in Electrical Engineering project implementation; both offer value to this position. Yes, it’s a lot but if you’ve read this far and you aren’t discouraged, read on.

 

RESPONSIBILITIES:

  • Defines/writes/implements Test Protocols (V&V)
  • Champion for Product/Process improvement using broad-based engineering experience to improve existing and develop new products
  • Defines Project requirements, specs and guidelines using robust engineering tools
  • May independently, or with the input of peers, design, build and implement electrical test equipment
  • Applying tools like MS Project; plans, defines resource needs, and schedules projects for completion consistent with corporate objectives and cGMP’s, adhering to FDA regulations and ISO
  • Prepares product specification documentation including cost estimates, reports, and presentations
  • Is a key participant/leader of Design Reviews and the Design Control process; writing V&V protocols, executing and reporting on results
  • Conducts Engineering Studies to support equipment, process and part selections as well as creating supporting documentation like drawings, material analysis and tolerance computations
  • Leads root cause analysis activities, resolving manufacturing/product related issues; implements ECN’s where appropriate; is involved with CAPA and/or NCR resolution
  • Provides direction and mentoring to techs and junior level engineers
  • Maintains a laboratory notebook
  • Interacts with Doctors and/or Clients relative to technical issues or questions

REQUIREMENTS:

  1. Bachelor’s Degree in an Engineering Discipline (e.g. Electrical, Mechanical, or Biomedical)
  2. 3-8 years’ experience in the Medical Device industry
  3. Knowledgeable in 21 CFR and ISO 13485
  4. Demonstrable experience with IQ/OQ/PQ and TMV
  5. Software knowledge with MS Office Suite, MiniTab, SolidWorks, AutoCAD, Altium, LabVIEW, Spice, Python, C++
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