Sr. Software Verification & Validation Engineer

Job Title: Sr. Software V&V Engineer

Pay rate: $45 - $50 per hour

Duration: Until 12-31-2025

W2 contract only (No C2C)

Location- 100 Indigo Creek Drive - Rochester, NY

Description

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 at 100 Indigo Creek Drive (CNP location).

Occasional travel required.

The 20% travel includes airplane, automobile travel and overnight hotel.

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

Requirements

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

This position is not currently eligible for visa sponsorship

Important information: To be immediately considered, please send an updated version of your resume to .