Senior R&D Engineer - Combo Device

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Location
New Hope, MN
Salary
$100,000 - $110,000
Job Type
Direct Hire
Date
Dec 07, 2017
Job ID
2548722
GR Identifier: $Medd, $NEER


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The Sr R&D Engineer works cross-functionally to lead research and development efforts of complex technologies on drug eluting medical devices. The position focuses on drug coating development and processing including; project planning, innovative catheter and coating designs, prototype development, testing, characterization, analysis and reporting.
 

Essential Job Functions

  • Coordinates and/or directs all aspects of product development activity related to a product line.
  • Coordinates product development activities of R&D/Product Development teams, including integration of RA, QA/QE, Operations, Clinical, Marketing, Sales and Packaging Engineering for a product line.
  • Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed.
  • Performs supervisory responsibilities for direct reports, including but not limited to, performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions and disciplinary actions.
  • Apply technical knowledge to innovate, design and develop processes, procedures, tooling and or automation.
  • Ensure process capabilities, prioritizing process improvement opportunities and implementing chosen improvements. 
  • Ensure proper documentation is complete and meets quality system requirements.
  • Oversee development builds associated with assigned projects.
  • Contribute ideas and/or generate intellectual property submissions.
 
Preferred Qualifications
  • Experience with balloon catheters, stents and stent delivery systems preferred
  • Experience in process validation (IQ, OQ and PQ), including writing protocols and reports to support verification and validation activities for product commercialization.
  • Experience in drug coating, active pharmaceutical ingredient handling, and working in controlled environment
  • Statistical analysis of data, pareto analysis, and other investigational tools
  • Demonstrated hands-on technical aptitude
  • Ability to travel to audit and/or transfer products to manufacturing partners
  • Excellent oral and written communication skills
  • Knowledge of cGMP and GLP
  • Knowledge of US FDA QSR and ISO 13485 requirements for design controls

Education and/or Experience

  • B.S. degree in Manufacturing Engineering, Mechanical Engineering or other related engineering discipline, or equivalent experience
  • 7 or more years of experience in R&D or process development
  • 3 or more years of medical device or other regulated FDA/QSR and ISO environment