Verification and Validation Senior Engineer – Onsite in Rochester, NY ($50/hr, Contract-to-Hire)
We are seeking a Verification and Validation Senior Engineer to support the formal verification and validation of complex medical devices under FDA regulations. This role requires working 100% onsite in Rochester, NY, with occasional travel (approximately 20%) involving air and automobile travel, as well as overnight hotel stays.
Key Responsibilities:
- Develop and execute requirements-based manual test procedures in a BL2 lab environment.
- Participate in formal reviews, test planning activities, and cross-functional collaboration.
- Work with software development teams and partners to reproduce and verify system defects.
- Design and implement software for embedded devices and systems.
- Conduct system software testing, debugging, and validation.
- Document and manage system software defects.
- Participate in team meetings and off-hour meetings with international partners.
- Support project goals and timelines to ensure product launch success.
- Perform other related duties as assigned.
Required Qualifications:
- Bachelor’s or Master’s degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related field.
- 10 years of experience, preferably in a medical device environment.
- Familiarity with software configuration management tools, defect tracking tools, and peer review processes.
- Knowledge of IEC 62304, ISO 13485, ISO 14971, and FDA QSR or equivalent FDA software development regulations.
- Strong analytical, problem-solving, and organizational skills.
- Experience in product development, experimental design, and risk management.
- Strong communication skills (written and verbal).
- Ability to work within cross-functional teams and manage multiple tasks.
- Knowledge of application lifecycle management (Agile preferred).
- Ability to write test plans, test cases, and test reports.
Work Environment:
- Location: Onsite in a BL2 lab environment.
- Conditions: May involve exposure to real patient samples, controls, and reagents.
- Temperature: Normal lab conditions, but some areas include cold storage (walk-in refrigerators/freezers).
- Noise Level: Equipment-heavy environment, which can be loud at times.
- Workspace: Traditional workspace with expected overtime and occasional early/late meetings with international teams.
Physical Demands:
- Sitting, standing, walking, lifting, carrying, reaching, pushing, and pulling.
- Bending, crawling, stooping, climbing, balancing, kneeling, crouching, and vision-related tasks.
- Ability to communicate effectively through talking and hearing.
Note: This position is not eligible for visa sponsorship.
If you meet the qualifications and are interested in this opportunity, please apply today!
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.