Senior Principal Engineer
Bayer•Indiana Township, PA
•$162,000 - $185,000•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.
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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What This Job Offers
Job Type
Full-time
Career Level
Senior
