Systems Engineer(Medical Device)(Only Fulltime) - Applab Systems Inc
Orlando, FL
About the Job
Job Title: Systems Engineer(Medical Device)(Only Fulltime)
Location: Orlando, Florida (Onsite)
Desired qualifications: Medical Device development experience with sound understanding of ISO 13485, IEC 60601, ISO 14971 Standards
Job Description
Works with marketing and/or product management to develop design input requirements from user and business needs.
Leads the generation of the system design input requirements.
Ensures tracing between user and business needs, and the design input requirements.
Makes sure design input requirements include safety risk management requirements, and human factors.
Evaluates/analyzes requirements for coherence and completeness and clarifies ambiguous requirements.
Support system architecture and design of new or next generation technologies/products
Contribute to system risk assessment activities, Use/Design FMEA activities
Supports system verification execution
Qualifications needed
BS or MS in electrical engineering, Computer Science, Biomedical Engineering or related field
Possesses systems engineering experience spanning the entire product lifecycle, including proficient use of systems engineering tools (e.g. requirements management, change control, etc.).
Systems engineering experience (at least 3 years) in a highly regulated industry
Knowledge of Software and System Architectures and design principles.
Experience using configuration management, test management, requirements management, and issue tracking systems.
Ability to lead teams through a structured approach to solving complex technical problems.
Strong knowledge of Design Controls & Risk Management practices
Strong personal credibility & excellent communication skills
Location: Orlando, Florida (Onsite)
Desired qualifications: Medical Device development experience with sound understanding of ISO 13485, IEC 60601, ISO 14971 Standards
Job Description
Works with marketing and/or product management to develop design input requirements from user and business needs.
Leads the generation of the system design input requirements.
Ensures tracing between user and business needs, and the design input requirements.
Makes sure design input requirements include safety risk management requirements, and human factors.
Evaluates/analyzes requirements for coherence and completeness and clarifies ambiguous requirements.
Support system architecture and design of new or next generation technologies/products
Contribute to system risk assessment activities, Use/Design FMEA activities
Supports system verification execution
Qualifications needed
BS or MS in electrical engineering, Computer Science, Biomedical Engineering or related field
Possesses systems engineering experience spanning the entire product lifecycle, including proficient use of systems engineering tools (e.g. requirements management, change control, etc.).
Systems engineering experience (at least 3 years) in a highly regulated industry
Knowledge of Software and System Architectures and design principles.
Experience using configuration management, test management, requirements management, and issue tracking systems.
Ability to lead teams through a structured approach to solving complex technical problems.
Strong knowledge of Design Controls & Risk Management practices
Strong personal credibility & excellent communication skills
Source : Applab Systems Inc
