Sr. Software V&V Engineer Job Listing at Kelly Services in Rochester, NY (Job ID US3576828_BH9796777)

Description

Sr. Software V&V Engineer
Location: Rochester, NY
Pay rate: $45-$48/per Hour

Position Details: 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 Occasional travel required.

• 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.

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. Would consider someone with 8+ years of experience who has US based experience and related fields of work (hospital settings, Medical Device and similar) 
• 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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Technology?

Looking to put your tech expertise to work on today's most intriguing, innovative, and high-visibility projects? By partnering with Kelly Technology, you'll gain direct connections to top companies around the globe. Our team creates expert talent solutions to solve the world's most critical challenges. In a world where change is the only constant, our extensive network of industry relationships and IT market expertise help you take your skills exactly where you want to go. We're here to help you gain experience, make an impact, and grow your tech career.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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