Sr. Instrument Verification and Validation Engineer

Integrated Resources, Inc ( IRI ); City of Rochester (NY); On-site; USD 61,992 - 68,880; Full time

Job summary

An established industry player is seeking a skilled Verification and Validation Engineer to join their dynamic team. This role involves the formal verification and validation of complex medical devices, ensuring compliance with FDA regulations. You will collaborate with a dedicated engineering team to design and implement software for embedded systems while developing test plans and procedures. If you have a passion for quality assurance in the medical field and a strong background in software development, this is an exciting opportunity to contribute to meaningful projects that enhance patient care and safety.

Qualifications

• 10+ years experience in medical device environment required.
• Knowledge of IEC 62304 and FDA QSR is essential.

Responsibilities

• Conduct formal verification and validation of medical devices.
• Develop and execute requirements-based manual test procedures.
• Document and manage software defects and test results.

Skills

Instrument V&V Theory & Application

Software Configuration Management

Defect Tracking Tools

Project Management

Test Plan Development

Agile Methodology

Statistical Analysis

Education

B.S. or M.S. Degree in Computer Science

Degree in Chemistry, Biochemistry, Biology, Engineering

Tools

Statistical Software

Spreadsheet Software

Graphing Software

Job description

Sr. Instrument Verification and Validation Engineer

2 days ago Be among the first 25 applicants

Integrated Resources, Inc ( IRI ) provided pay range

This range is provided by Integrated Resources, Inc ( IRI ). Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$45.00/hr - $50.00/hr

Job Duration

12+ months

NOTE:

• 20% of travel includes airplane, automobile travel and overnight hotel.
• Overtime is expected. Early or late meetings with China Partners.

Job Description:

• As we continue to grow as ***, we are 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.
• Designing and implementing software for embedded devices and systems.
• Designing, developing, coding, testing, and debugging system software.
• Develop Requirements based manual test procedures.
• Access requirements for testability and determine the 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.

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.
• Experience in product development and experimental design.
• 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.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Science, Research, and Engineering

Industries

Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing