Senior Instrument Verification and Validation Engineer

On-Board Companies; New York (NY); On-site; Full time

Job summary

An established industry player is seeking a Senior Instrument Verification and Validation Engineer to join their dynamic team in Rochester. This role involves formal verification and validation of complex medical devices under FDA regulations, requiring a collaborative approach to design test cases and execute procedures. The ideal candidate will have a strong background in software development and project management, along with excellent analytical and problem-solving skills. This position offers a unique opportunity to contribute to innovative diagnostic solutions that enhance healthcare outcomes. Join a team that values employee happiness and fosters professional growth in a supportive environment.

Benefits

401K

Dental Insurance

Life Insurance

Medical Insurance

Vision Insurance

Qualifications

• 10+ years experience in medical device environments preferred.
• Knowledge of IEC 62304, ISO 13485, and FDA QSR regulations required.
• Experience in product development and experimental design.

Responsibilities

• Design and implement software for embedded devices and systems.
• Develop manual test procedures based on requirements.
• Document and manage system software defects.

Skills

Analytical Skills

Problem-Solving Skills

Communication Skills

Organizational Skills

Project Management

Software Development

Test Plan Writing

Cross-Functional Team Collaboration

Education

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

Degree in Chemistry, Biochemistry, Biology, Engineering

Tools

Software Configuration Management Tools

Defect Tracking Tools

Statistical Software

Spreadsheet Software

Graphing Software

Job description

On-Board Services is hiring a
Senior Instrument Verification and Validation Engineer
in Rochester, NY!

For immediate consideration please send your resume to [e-mail]
Subject Line: Position Title and State you are Located.

About Us:

On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.

Position Details:

Position Type: Contract
Job Location: Rochester, NY
Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance
Compensation: $46.66 - $51.85 (based on experience)

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

Overview:

This client unites the strengths of the Corporation and the Company, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. They are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. They strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

As we continue to grow as a company, 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.

Qualifications:

• 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.

Requirements:

• 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.

Other physical demands include:

• Bending
• Crawling
• Stooping
• Vision
• Climbing or balancing
• Kneeling
• Crouching
• Talking or hearing

Environmental:

• 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.

Apply Today!

www.onboardusa.com

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.

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