Software Validation Engineer

Company: Clerio Vision
Location: Rochester
Posted on: November 25, 2022

Job Description:

*Software Verification and Validation Engineer*

Clerio Vision is looking for an enthusiastic Validation/Verification professional to join their growing team.

The ideal candidate will be integral to the System/Software engineering team by applying their knowledge and expertise in the validation of software and systems used to manufacture LIRIC contact lenses. Typical systems have integrated hardware and software components requiring verification and validation. We are seeking a candidate with effective scientific and workplace communication skills.

Primary job duties include:

-- Participating in early phases of engineering projects (e.g. use cases, user scenarios, etc).

-- Authoring verification and validation plans and corresponding reports.

-- Creating test cases with test scripts to verify requirements.

-- Maintaining the requirements-test traceability matrix.

-- Coordinating test case execution with available test personnel and resources.

-- Documenting actual test results and forwarding defects to the engineering team for review.

-- Facilitating the disposition of any outstanding failed tests.

-- Participating in Risk Management activities.

-- Coordinating the completion of documentation in compliance with the design process.

-- Participating in design reviews.

-- Contributing to follow-up requirements reviews.

-- Contributing to IOPQ protocols.

*Qualifications (Required)*

1. BS degree in an engineering or science discipline

2. Min 2yrs experience as a validation/verification/QA/test engineer.

3. Experience using lifecycle management tools for requirements management and/or QA test management. (e.g. JAMA, Jira, et al)

4. Familiarity with applicable FDA standards and regulations including:

a. 21 CFR Part 11

b. 21 CFR Part 820

c. IEC 62304

d. ISO 13485

e. ISO 14971

f. GCP and GDP

*Qualifications (Desired)*

1. Familiarity with software development life cycle (SDLC) models and frameworks.

2. View toward test automation.

3. Experience in medical device, medical software validation.

4. Experience in clinical trial system validation.

Job Type: Full-time

Pay: $65,000.00 - $80,000.00 per year

Benefits:
* 401(k)
* 401(k) matching
* Dental insurance
* Health insurance
* Health savings account
* Life insurance
* Paid time off
* Parental leave
* Vision insurance
Schedule:
* Monday to Friday

COVID-19 considerations:
The physical environment of this role is well-suited for protecting employees from COVID-19. Our office is well-equipped with PPE such as surgical masks.

Education:
* Bachelor's (Preferred)

Experience:
* V&V, QA, test engineering: 2 years (Preferred)

Work Location: One location%58047475%

Keywords: Clerio Vision, Rochester , Software Validation Engineer, Other , Rochester, New York