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Principal Engineer

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Job Type
Direct Hire
Jan 02, 2019
Job ID

Our start-up medical device client is developing a novel transcatheter device used to treat mitral regurgitation. This is a new position where the Principal Engineer will participate in the selection of an overall concept and development of a full product development cycle.  In addition, this individual will assist the Director, Product Surveillance in developing infrastructure related tools as it relates to all companies programs.

Your role with the company:
  • Participate in the design and development approach of a Transcatheter Mitral Valve program (System Approach – Implant + Delivery System Integration) 
  • Contribute to the existing Transapical program for various design improvement activity     
  • Develop internal Design of Experiments (DOE) methodology and overall approach for exploring device design space and process windows for the various programs 
  • Develop test methods and test protocols to verify and validate programs 
  • Actively participate in Project Planning for early and full product development cycle activity 
  • Provide guidance, mentoring and learning opportunity for engineers across company based on previous experience and new areas related to development (i.e., new material or processing approaches)
  • Work directly with vendors for components, sub-assemblies as related programs (
  • Reduce cost of goods through cost analysis, supplier sourcing, increasing manufacturing efficiency, and initiating innovative design changes 
  • Participate in development of early stage prototyping and pilot line capability for the delivery system 
  • Assist Quality Assurance and Quality Control as defined by the quality function 

Desired Profile:
  • Minimum 4 years of post-secondary education in the field of Applied Science (Engineering preferred) in a related discipline or equivalent combination of education and experience

> 10 years’ experience in a medical device and manufacturing environment

  • Previous supervisory experience a plus 
  • Previous project management experience
  • Experience in R&D and Manufacturing roles
  • Strong Catheter experience for both design and manufacturing (steering catheter experience a plus)
  • Working directly with vendors for early stage and long-term cost-effective solutions within production 
  • Demonstrated experience in new product introduction
  • Strong understanding of Design Controls methodology
  • Strong DOE and Statistical Skill Set a must have
  • Strong analytical and problem-solving skills
  • Strong understanding of best practices for Design for Manufacturability
  • Strong understanding of variability analysis and variability control/ reduction methods
  • Strong understanding of Risk Analyses (DFMEA, PFMEA)
  • Strong understanding of Design Validation
  • Ability to handle ambiguity
  • Strong computer skills (e.g., Microsoft Software, Adobe, etc.) 
  • Ability to prioritize and handle numerous tasks on multiple projects
  • Project management tools a plus 
  • Strong communication and organizational skills (upward/downward through the organization and cross functionally)
  • Knowledge of CAD software programs such as Solidworks or ProE
  • Finite Element Analysis (FEA) and/or Computational Fluid Dynamics (CFD) a plus
  • Hands on experience with machines, tools and metrology/test equipment
  • General Mechanical Aptitude
  • Proven ability to provide leadership and mentoring to fellow engineers