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Job Requirements of Senior Instrument Verification and Validation Engineer:
-
Employment Type:
Contractor
-
Location:
Rochester, NY (Onsite)
Do you meet the requirements for this job?
Senior Instrument Verification and Validation Engineer
Careers Integrated Resources Inc
Rochester, NY (Onsite)
Contractor
Designing and implementing software of embedded devices and systems
Designing, developing, coding, testing, and debugging system software
Develop Requirements based manual test procedures
Access requirements for testability and determine best test approach
Compile and analyze test results
Document and manage system software defects
Participate in regular scheduling and team meetings
Participate in regular off hour meetings with partner in China
Understand project goals and timelines, and provides support to ensure product launch success
Perform other work- related duties as assigned.
seeking a Verification and Validation SR Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA. The individual will be part of an engineering team that is responsible for requirements based manual test case design and execution of test procedures in a BL2 lab environment. The team is highly collaborative and will require regular interactions in formal reviews, test planning activities, and working with software development and partners to reproduce and verify system defects. The job is 100% onsite. Occasional travel required. The 20% travel includes airplane, automobile travel and overnight hotel.
Required Skills:
B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline required.
10+ years required, preferably in a medical device environment.
Familiarity with software configuration management tools, defect tracking tools, and peer review
Instrument V&V Theory & Application
An understanding of IEC 62304 (Medical Device Software Lifecycle process), ISO 13485, ISO / EN ISO 14971, and FDA QSR experience or equivalent FDA software development requirements
Good analytical and problem-solving skills
Good organizational skills, and the ability to manage multiple tasks
Experience in product development and experimental design
Ability to work within cross-functional teams
Strong communication skills, written and verbal
Must exhibit professionalism, confidence, maturity, desire to succeed, and a self-motivated and proactive orientation.
Ability to participate in planning and managing projects
Working knowledge of product development tools and processes (e.g. Design Input, Design Output, Verification and Validation, Product Risk Management)
Knowledge of related quality systems regulations and processes
Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)
Knowledge of Application life cycle management (Agile method preferred).
Know and understand the software test cycle.
Ability to write test plans, test cases and test reports.
A job description's work environment section should describe the conditions in which the job applicant will perform their duties. This includes factors that may affect the person's working conditions, such as:
Temperature: Normal Lab conditions, however, walk in fridge/freezers will be cold.
Noise level: BL2 lab with a lot of equipment. Can be loud at times
Location: Inside
Weather: Normal Lab conditions
Exposures: BL2 using real patient samples, controls and reagents.
Workspace: Traditional workspace
Other factors: Overtime is expected. Early or late meetings with China Partners
Designing, developing, coding, testing, and debugging system software
Develop Requirements based manual test procedures
Access requirements for testability and determine best test approach
Compile and analyze test results
Document and manage system software defects
Participate in regular scheduling and team meetings
Participate in regular off hour meetings with partner in China
Understand project goals and timelines, and provides support to ensure product launch success
Perform other work- related duties as assigned.
seeking a Verification and Validation SR Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA. The individual will be part of an engineering team that is responsible for requirements based manual test case design and execution of test procedures in a BL2 lab environment. The team is highly collaborative and will require regular interactions in formal reviews, test planning activities, and working with software development and partners to reproduce and verify system defects. The job is 100% onsite. Occasional travel required. The 20% travel includes airplane, automobile travel and overnight hotel.
Required Skills:
B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline required.
10+ years required, preferably in a medical device environment.
Familiarity with software configuration management tools, defect tracking tools, and peer review
Instrument V&V Theory & Application
An understanding of IEC 62304 (Medical Device Software Lifecycle process), ISO 13485, ISO / EN ISO 14971, and FDA QSR experience or equivalent FDA software development requirements
Good analytical and problem-solving skills
Good organizational skills, and the ability to manage multiple tasks
Experience in product development and experimental design
Ability to work within cross-functional teams
Strong communication skills, written and verbal
Must exhibit professionalism, confidence, maturity, desire to succeed, and a self-motivated and proactive orientation.
Ability to participate in planning and managing projects
Working knowledge of product development tools and processes (e.g. Design Input, Design Output, Verification and Validation, Product Risk Management)
Knowledge of related quality systems regulations and processes
Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)
Knowledge of Application life cycle management (Agile method preferred).
Know and understand the software test cycle.
Ability to write test plans, test cases and test reports.
A job description's work environment section should describe the conditions in which the job applicant will perform their duties. This includes factors that may affect the person's working conditions, such as:
Temperature: Normal Lab conditions, however, walk in fridge/freezers will be cold.
Noise level: BL2 lab with a lot of equipment. Can be loud at times
Location: Inside
Weather: Normal Lab conditions
Exposures: BL2 using real patient samples, controls and reagents.
Workspace: Traditional workspace
Other factors: Overtime is expected. Early or late meetings with China Partners
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