Team Lead Validation Engineer :: San Jose, CA :: Onsite

Hi,
This is Prashant, a Senior Recruiter from Triunitysoft, Inc. a leading staffing organization
I came across your profile in one of the job boards and feel that your skills and professional experience would be a good fit for a position with one of our premier clients. Please review the job description below
If you are interested in this position, please forward your updated resume for immediate consideration and preferred time to discuss this opportunity further
Title: Team Lead Validation Engineer
Experience: 8 - 10 years
Location: San Jose, CA, USA
Education: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engg. / M.S. Mech. Engg.
Note: Candidate looking for who worked on Medical Devices OR Companies who Manufactures Medical Devices
The experience looking for is as follows:
• 6 years relevant experience in medical device manufacturing.
• Clean room environment experience
• Experience with Test Method Validation and/or Measurement System Analysis is preferred.
• Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
• Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
• Strong organizational skills, detail oriented.
• Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
• Ability to work to a deadline and to handle multiple tasks simultaneously.
• Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint.
• Experience with 3D CAD Software SolidWorks
• Experience working with Engineering change management software & releasing engineering change orders.
Job duties:
• Process and equipment qualification (IQ/OQ/PQ).
• Development of test methods for Design V&V, Process Validation, and Production
• Validation of test methods
• Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work
• Authoring/releasing of new test methods and editing/redlining of old test methods
• Experience working in a regulated and/or medical device environment
• To define equipment requirements
• To draft equipment specifications
• To work on change management and releasing engineering change orders
• To design process validations and identify critical process parameters related to equipment Working
Compensation: $60.00 - $70.00 per hour
About Us
Triunity is a Product Development, Staff Augmentation, and Consulting Services company providing solutions and services in North America. We provide IT services and technology solutions to various business verticals like Healthcare, Pharma, Banking, Finance, etc. Our goal is to develop a long-term partnership with businesses and help them get a competitive advantage by providing IT infrastructure and software platforms.
Lead by experts in the IT industry with a proven record of delivering software solutions, consulting, and staffing services, we have expertise in fulfilling client needs in terms of customized business solutions as well as IT consulting. At Triunity, we always try to bring the right mix of skills, technologies, and experts together which helps our clients to stay ahead in the competition. Our goal is to make our clients empower with cutting-edge technologies and take care of all their IT needs so they can focus more on their core business.
Triunity Culture
Our core value is our people and our teams . We believe the real mantra of success is like minded people with right mix of technical and analytical skills. Our strength lies in bringing right set of people and delivering work as a team. Be it expert or intern Triunity always always value its own people and give them platform to excel in their career.
At Triunity you can expect

• Challenging & Friendly
• Work on new edge technologies & tools
• Work with industry experts
• Solving complex client problems and delivering solutions
• Working on projects lasting from six months to several years

Careers & Growth Model
At Triunity people are motivated by the complexity and challenges they face when working on client projects . We always motivate our people to keep learning new technologies and also give them platform where they can get chance to show their technical and analytical skills . We help our people in adding latest technologies ,tools, methodologies and certifications to their resume by arranging trainings , seminars and knowledge sharing sessions.