C. R. Bard, Inc.

Sr/Principal R&D Engineer

2 weeks ago
Industry / Category
Sr. R&D Engineer
Job ID
2017-10866
Career Level
experienced
Division
New Hope, MN / Lutonix
Relocation
Relocation Not Available
US-MN-New Hope

Summary of Position with General Responsibilities

The Sr/Principal 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.

Additional Desirable Qualifications Skills and Knowledge

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

To be considered for Principal level must have all of the above requirements plus

  • 10 or more years of experience in R&D or process development
  • 2 or more years of experience providing work direction to other engineers/technicians

 

Physical Demands

While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. Bard Lutonix is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

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