Senior Engineer, Product Development

5 - 7 years experience  •  Healthcare IT

Salary depends on experience
Posted on 08/09/17
Bend, OR
5 - 7 years experience
Healthcare IT
Salary depends on experience
Posted on 08/09/17

As a Senior Engineer, Product Development you will contribute as part of a cross functional team on internal and/or client projects to develop and execute work plans against specific hypotheses and problem statements. You will also be responsible for delivering high quality, scientifically sound experimental plans and resulting data sets to advance products through the development lifecycle.

 

Duties include but are not limited to the following:

  • Understand and apply chemical and engineering fundamentals including chemistry, materials science, heat and mass transfer, fluid mechanics, thermodynamics, conservation of mass and energy, and basic mathematical modeling
  • Collaborateswith client and internal multi-disciplinary team members to define formulation, process, and product development approach
  • Review, interpret, and react to data in order to drive product development progression
  • Formulate and present experimental results to internal teams and/or clients
  • Support scheduling and coordinating of work plan execution to ensure safe, high quality, and on time delivery of project milestones across multiple projects
  • Advance appropriate models to relate key product attributes to material attributes and process parameters
  • Prepare estimate of development costs for management, clients, and other stakeholders
  • Prepare written documents such as standard operating procedures, memos, reports, and tech transfer documentation
  • Serve as subject matter expert (SME) / technical expert in specific area(s) of expertise as required across portfolio of programs/products
  • Assist and support GMP manufacturing by participating in activities, including, but not limited to: development study design and execution, training, clinical tech transfer, investigation support, product commercialization and ongoing product support, equipment design and qualification, and change control.
  • Evaluate pharmaceutical equipment and processes to identify ways to optimize performance or to ensure compliance with safety and environmental regulations
  • Build development and regulatory knowledge base to support specific program goals such as regulatory submissions
  • Identify opportunities for new technologies and/or improvements to existing technologies

 

Position Requirements

  • Requires a university degree and 5+ years of related experience
  • In-depth knowledge of GMP is required
  • Experience providing technical and development support to clinical and commercial manufacturing groups is required
  • Experience working with clients and technical teams is required
  • Solves complex problems; takes a new perspective using existing solutions
  • Works independently; receives minimal guidance
  • Acts as a resource for colleagues with less experience

 

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