Program Manager

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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Program Manager

  • Specialty:

    Engineering
  • Title:

    Program Manager
    • City:

    • State:

      MA
    • Zip Code:

      01826
  • Start date:

    11-26-2019
  • Status:

    Closed
  • Assignment Type:

    Direct Hire
  • Job Id:

    51632

Description

Program Manager

Responsibilities:

  • Leads research and development combination product programs and identifying novel technology enhancements to therapeutic drug delivery systems to meet patient demands in the CNS and Intrathecal drug delivery arena.
  • Helps to evaluate materials and technologies used to develop products.                
  • Leads development programs from concept to launch, working as a core team leader of the product development team and will work closely with all cross functional team members to coordinate activities and development strategies.              
  • Deals with partner companies and corporate groups in addition to consultants, contractors and vendors.
  • Proactively manages and communicates technical and financial risks.      

Experience:

  • Bachelor’s degree in a technical engineering discipline and of 7+ years of work experience in med device or biotech.
  • Demonstrated experience working in the medical device industry (product development, design control documentation and risk analysis, quality assurance and regulatory standards
    • ISO 13485            
    • QSR 21 CFR Part 820 related to Class I, Class II, and Class III medical device development.
  • Experience with combination devices and regulatory submission required.           
  • Experience in working cross functionally with R&D, clinical, product development, and regulatory teams for device manufacturing.  
  • Experience in working with regulatory team on early stages of the product development process through FDA regulatory submission. 
  • Experience in 510(k) and/or PMA submission process
  • Experience in pre-clinical studies for medical devices is a plus.    
  • Experience working in a startup company desired.           

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