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Device Industrialization Lead
Ref No.: 15-01550
Location: Cambridge, Massachusetts
Position Type:Contract
Start Date / End Date: 07/06/2015 to 07/01/2016
Job Title: Device Industrialization Lead
Job Location: Cambridge, MA
Job ID: 15-01550
 
Job Description:
  • Client is seeking a qualified candidate to support the Device Industrialization Lead within the Device Development team.
  • The position will provide technical oversight of device partners and lead the technology transfer efforts of new combination products and devices.
  • These projects will leverage both internal and external manufacturing sites from clinical development through registration, and provide ongoing commercial support.
  • This person can work remotely.
     
Responsibilities:
  • Report to the Senior Engineer, Device Industrialization.
  • Responsible for multi-component drug delivery device assembly scale-up from development through validation and transfer into commercial scale manufacturing.
  • Analyze designs for function, manufacturability, and assembly robustness.
  • Responsible for management of third parties contracted for tool making, injection molding, and manual/automated assembly processes.
  • Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
  • Work with and manage key interfaces and line functions in manufacturing, quality assurance and regulatory to progress device development deliverables.
  • Resolve technical issues during development and manufacturing scale-up.
  • Potential for domestic and International travel up to 10%
     
Qualifications:
  • 10+ years' experience in medical device tooling, injection molding, assembly equipment, and production controls for assembly.
  • Deep understanding of new product introduction, design and development of molded and/or assembled devices & combination products.
  • 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 ability to facilitate the interface between the biopharmaceutical company and medical device vendors.
  • Strong understanding and application of validation processes (IQ/OQ/PQ) in combination product device manufacturing.
  • 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.
     
Education:
  • Bachelor's Degree in Engineering required.
  • Master's Degree with Electromechanical or Mechanical experience preferred- plus 10+ years' experience.