Senior Systems Engineer Radiology Research and Early Development
About The Position
This role is for a Senior Systems Engineer in Radiology Research and Early Development in Indianola, PA. The primary responsibilities include designing and developing new medical device products to meet customer needs and technical/regulatory requirements. The engineer will support new product development from early stages through launch, identify requirements, analyze and design system architectures, perform hazard analysis and mitigation, and guide hardware and software design direction while collaborating with cross-functional teams. The position may involve telecommuting from a home office within a reasonable commuting distance of Indianola, PA, up to one day per week, with up to 10% US travel required.
Requirements
- Master’s in Biomedical, Systems or Mechanical Engineering or closely-related technical field
- 2 years of experience in a medical device design and/or engineering position
- Performing new product medical device and/or combination product design
- Creating & maintaining DHF documentation throughout design control process
- Developing verification & validation activities to meet patient, customer, and regulatory requirements
- Creating pre-submission content & presenting to US FDA in Type-C & Pre-Submission meetings
- Applying FDA, NRC, DOT, ICRP and IAEA regulations pertaining to radioactive material use
- Applying AAMI TIR 101, Total Product Life Cycle Guidance for Infusion Pumps to design & testing of infusion systems
- Developing test protocols and/or microbiological methods to identify sources for microbial contamination & performing required V&V testing
Responsibilities
- Design & develop new medical device products in accordance with customer needs and technical and regulatory requirements
- Support new product development programs from early development to launch
- Identify requirements
- Analyze & design system architectures
- Perform hazard analysis & mitigation
- Guide hardware & software design direction
- Work with cross-functional teams
Benefits
- health care
- vision
- dental
- retirement
- PTO
- sick leave
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What This Job Offers
Job Type
Full-time
Career Level
Senior
