Software Engineering Jobs - Director of Software Engineering, 15012

at Kelly Engineering Resources
Location Waltham, MA
Date Posted April 17, 2019
Category Default
Job Type Full-time


Our client provides full service medical device product development from concept through commercialization.  They are a small group of hands-on engineers who work with our customers on complex design ideas, transforming them into viable devices.  They are 100% medical and combine a passion for engineering with solid expertise to offer practical solutions in a wide range of clinical subspecialties.
This individual is part of the senior management team and manages software engineering for all aspects and phases of medical device development projects. 

  • Contribute to management team discussions and decisions on operational and strategic issues to ensure that the company’s goals are met.
  • Identify business opportunities, meet with potential clients, generate proposals for software development.
  • Communicate with clients as part of the overall program management process.
  • Manage and grow a team of software engineers working on a variety of projects.
  • Generate quality procedures relevant to software development to keep company's compliant with FDA requirements and the latest revision of ISO 62304.
  • Contribute to the design and development of medical devices, systems, and standalone software from concept through market introduction and design for manufacturing. 
  • Produce prototype software for testing and evaluation by client companies.
  • Prepare software documentation release packages.  Prepare Document Change Orders (DCOs) to release documentation.
  • Identify software development needs. Specify and purchase components, equipment, materials and supplies. Identify and interact with vendors.
  • Generate job descriptions for software personnel, drive hiring for the software group. Supervise personnel.
  • Contribute to product and software verification and validation testing to demonstrate product safety and efficacy including EMC/Electrical Safety (60601, 61010, etc.). Develop protocols, plan testing, and coordinate/perform testing. Write test reports which draw conclusions from the results.
  • Ensure that all work satisfies the requirements of the company's Quality Manual, with particular emphasis on Design Control.


  • Bachelor's degree in Electrical/Software Engineering. Other advanced degrees may be advantageous or considered.
  • Minimum of 15 years of medical device product design and development experience is required.
  • Demonstrated ability to bring products from concept to market.
  • Ability to interact with client companies in a professional manner.
  • Familiarity with FDA QSR and ISO 13485 medical device regulations.
  • Familiarity with risk documentation and ISO 14971
  • Familiarity with Usability considerations in design of medical products and IEC 62366
  • Depth of knowledge in one or more clinical and product areas.
  • Depth of knowledge in one or more technical areas, for programming and software life cycle controls.

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