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Principal R&D Engineer - CNS Medical Device in Cambridge at Apple & Associates

Date Posted: 2/5/2019

Job Snapshot

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Job Description

The Principal R&D Engineer is Creating and Implementing innovative solutions for Central Nervous System ( CNS ) drug delivery products that will lead to a new platform of cutting-edge technology products for this market!

The Principal R&D Engineer will lead the novel technology area of device development, with a focus on delivery to the central nervous system (CNS) and other routes of administration like SC, IM, IV, aligned to the drug pipeline, as well as execute deliverables with internal stakeholders and external partners for the company for all of the device and combination products in the future portfolio. 

Principal R&D Engineer Responsibilities:

  • Report to the Sr Director of Medical Device R&D
  • Lead and hands-on involved with device development and leadership of the team and relevant cross functional groups in creating innovative solutions aligned to the drug device pipeline.
  • Evaluate and identify device landscape for innovative and implementable solutions, with drug delivery to Central Nervous System, CNS as a target area. Example Intrathecal, Direct and Indirect to Brain
  • Evaluate and Identify device landscape for delivery to IV, SC and IM Route of Administration, when needed
  • Subject Matter Expert for global platform device technology and required interface/interaction with Drug Molecule development, Container Systems and secondary Packaging 
  • Analyze designs for function, assembly, manufacturability, etc. using Engineering techniques.
  • Liaise with third parties such as specialist manufacturers, contract manufacturing, design firms and consultants
  • Responsible for device selection and liaison with cross functional stakeholders in Early and Late stage development and LCM projects
  • Provide technical leadership and responsibility for device technologies
  • Ensure essential platform design robustness is based upon agreed Design for Manufacturing, Assembly and Testing principles (DFM and DFA)
  • Work and manage key interfaces and line functions in manufacturing, quality assurance, manufacturing and regulatory to progress device development deliverables.

Principal R&D Engineer Qualifications:

  • 10+ years’ experience in medical device design with a minimum of 2 years experience with drug delivery to the CNS System, Spine or Brain (Intrathecal, pain pump, implant or vascular)
  • Deep understanding of new product introduction NPI, design and development of medical device, device/ drug combination assembled device products as well as testing and modeling methodologies. 
  • Deep knowledge of the regulatory and compliance requirements of device design controls and combination products. ( i.e. FDA QSR 21 CFR 820 / ISO13485 quality system requirements)
  • Demonstrated patient centered design emphasis and Human Factors experience preferred. 
  • Experience developing multiple device and combination product device products from research through registration and launch.
  • Strong communication, collaboration and team building skills; ability to connect with all levels of the organization 
  • Comfortable working in a matrix environment, while embracing and driving change

Principal R&D Engineer Desired Qualifications:

  • Bachelor’s Degree in Engineering required, Master’s Degree or MBA with mechanical or biomechanical or electromechanical experience preferred- plus 10 - 12+ years’ experience that includes CNS delivery medical device products.