Quality Engineer (Software /Apps), RTP Area Medical Device– Direct Hire

Job Type: 
Information Technology
Other Life Science Positions
Employment Category: 
Direct Hire

Our client, an RTP area medical device company in high growth mode, is actively recruiting for a sharp and capable Software Engineer to join its Quality Engineering team.

This company is using its proprietary technology to develop regenerative therapies for a wide range of medical conditions, some chronic.  This Engineer will be tasked with leading and maintaining the quality of the compatible application software used in the company’s leading medical device.  This role will be focused on the quality documentation for the applications software.

Responsibilities will include:

  • Creating documentation within software/product life cycle phases, assuring quality and compliance as it relates to design controls and applicable medical device standards
  • Authoring, executing and summarizing verification and validation studies to support product/software changes
  • Leading ongoing technical support, complaint investigations and CAPA investigations as it relates to the software
  • Leading Computer System Validation efforts, to include documentation of requirements, risk assessment, validation, and maintenance
  • Administration, maintenance and improvements to the quality system
  • Involvement in preparation of regulatory submissions

This Quality Software Engineer will be involved in ensuring the quality of the applications software as it relates to the medical device.  Experience with Quality documentation will be important.  

The right candidate will offer a related degree and 3-7+ years of experience working with medical devices and software applications within an ISO 13485 and FDA compliant space.

Other priorities include:

  • Experience with Medical Device Software standards, IEC 62304
  • Experience with Quality documentation in the software applications space
  • Experienced with embedded systems firmware development in C/C++ for microprocessors
  • App development for iOS and Android experience
  • User experience, GUI design, and implementation a plus
  • Excellent organizational skills and keen attention to detail

Finally, this is a young and highly dynamic company.  Successful team members are hands-on, flexible and collaborative.  A lot is happening and the future is bright.  We seek an Engineer who is eager to contribute, and ready to thrive. 

This is an immediate need.  Please forward Word resume for prompt consideration.