Senior Principal Engineer

Bayer Healthcare LLCIndianola, PA
Hybrid

About The Position

Senior Principal Engineer for Indianola, PA to lead medical device software product design & development for radiology product portfolio; gather & develop requirements; assess regulatory design controls & industry standards; translate requirements into application features; support software testing, design review, & verification and validation activities; contribute to regulatory documentation & submissions; provide input for technical design & architecture decisions; work as part of team to coordinate priorities & deadlines; mentor junior team members. Position may telecommute from home office location within reasonable commuting distance of Indianola, PA up to 1 day per wk. Up to 5% US & int’l travel req’d.

Requirements

  • Master’s in Computer, Electrical, Electronics, or Mechanical Engineering or closely-related technical field & 4 yrs experience in senior-level medical device product development position(s): designing and developing embedded application software for radiology injection systems across the complete software development lifecycle
  • Architecting software systems and/or sub-systems, including imaging system interfaces
  • Applying medical device standards for Class-2 medical device development, including ISO 11898-1 & CiA 301, 425-1 and 425-2
  • Programming in C & C++ for Linux and Windows cross-platforms and/or real-time operating systems
  • Writing code in JSON, gRPC, TLS, TPM, Qt, Shell, & Python to develop product security features and test tools, including injector & scanner simulations
  • Implementing complex integrations with DICOM, HL7, & MIRTH Connect
  • Using GitHub, Windchill, RQM, DNG & Jira to manage source code, test cases, requirements & related Design History File documentation
  • Bachelor’s in said fields & 6 yrs progressive, post-Bachelor’s stated experience

Responsibilities

  • Lead medical device software product design & development for radiology product portfolio
  • Gather & develop requirements
  • Assess regulatory design controls & industry standards
  • Translate requirements into application features
  • Support software testing, design review, & verification and validation activities
  • Contribute to regulatory documentation & submissions
  • Provide input for technical design & architecture decisions
  • Work as part of team to coordinate priorities & deadlines
  • Mentor junior team members

Benefits

  • health care
  • vision
  • dental
  • retirement
  • PTO
  • sick leave
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