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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
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Job Snapshot

Employee Type

Contractor

Location

Rochester, NY (Onsite)

Job Type

Engineering

Experience

Not Specified

Date Posted

03/25/2025

Job ID

25-41708

Apply to this job.

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