Participate in firmware and process development for combination products.
Responsibilities include authoring software documentation, implementing software, test, integration, and formal verification.
Senior Engineer will be a technical hands-on professional experienced with embedded software development in medical devices.
The Senior Engineer will be proficient in medical device development life cycle and design guidance requirements.
The senior engineer will participate in software development activities including requirements, design, implementation and verification for complex electromechanical drug delivery devices.
The Device Engineering, Electrical and Software Development department leads the development of the electrical, software, and firmware subsystems of electromechanical drug delivery devices.
Key responsibilities of the Senior Engineer include:
Participate in defining software requirements
Participate in software design
Develop software code
Develop test for software unit verification
Develop test for software system verification
Perform software unit test and software verification test and generate reports
Perform software test tool requirement analysis, design, implementation and validation
Work with tools for software configuration management, software build and software verification
Follow a disciplined product development process and participate in technical reviews and ensure robust deliverables and documentation traceability.
Execute to project plans and schedules, providing high quality, on time, and on cost results.
Master's Degree and 3 years of Engineering experience
Bachelor's Degree and 5 years of Engineering experience
Associate's degree and10 years of Engineering experience
High school diploma/GED and 12 years of Engineering experience
5+ years of experience in software/firmware development.
Experience in Medical Device development life cycle and knowledge of design control.
Experience with formal testing and generating test protocol & reports
Extensive experience in microcontroller-based hardware and software designs, familiarity with various microcontroller architectures
Familiarity with lab instruments such as oscilloscope, logic analyzer, and simulators.
Strong problem solving, risk assessment, and risk management skills.
Familiar with the following standards: Quality System Regulation – 21CFR820, Quality Management – ISO 13485, Risk Management – ISO 14971, EU Medical Device requirements – Council Directive, 93/42/EEC, Medical Electrical Equipment – EN 6060, Medical Device Software Standard – IEC 62304, ISO 11608 Needle-based injection system for medical use
Proficiency in C programming language
Knowledge of STM8 microcontroller, gitlab, jenkins, ALM, and doors
"This posting is for Contingent Worker, not an FTE"