Validation Application Specialist

Job Description:

Title: Validation Application Specialist

Duration: 12 Months (Extendable)

Location: Indianola, PA,15051

Summary

Job Overview

• The successful candidate will perform the following:

• Support activities for multiple new product development (NPD) and Life Cycle Engineering (LCE) on injector projects with specific focus on how the systems are practically used in the field.

• Accomplish V&V program activities on time working with cross-functional resources. This position will ensure that all system verification and customer centric validation activities fulfill design requirements and specifications and the respective products fulfill their intended use.

• Consult with the design teams in specifying appropriate day-in-the-life of the Injector in various modalities namely, CT, MR, PET and Interventional suites.

• Support continuous improvements and process initiatives to further center of excellence in V&V engineering, especially by bringing end-user knowledge to the team.

• Co-ordinate and support the cross-functional teams in the creation and execution of V&V plan, verification protocols, dry runs, validation of test set-ups to simulate practical use environments, and completion of verification reports.

• Capture discrepancies during planned verification and/or validation testing, if needed; aid in driving them to resolution through the discrepancy review management process, if participating in the review.

• Guide the design team in developing solid use cases, task analysis, workflows, etc. and support technical reviews and cross-functional documentation reviews.

• Participate in early concept assessments and provide user-oriented feedback.

• Adapt with changing workload to meet budgets and timelines, and assess priority based on impact to overall business.

• Present complex technical information to an audience of varied expertise/level for guidance, education and credibly influence technical direction and specific decision-making.

Qualifications / Experience

• The successful candidate will have the following:

•

Minimum Qualification:

• Qualified to be a Radiology Technologist for CT, MR or PET imaging with a minimum of 10 years clinical experience.

Special Skills/Knowledge:

• Thorough understanding of Power Injector Systems of or other OEMs and hands-on use of these injectors in the clinical setting.

• Good knowhow about different Radiology work-flows.

• Understanding of Healthcare IT (Informatics) associated products (eg. HIS, RIS, PACS, etc.)

• Prior working experience in a regulated environment following Quality controlled process with knowledge of documentation systems.

• Work experience running scan sequences on patients in a minimum of one modality required. More than one modality of CT, MR, PET and CATH labs a plus.

• Candidate must possess demonstrated ability working in a matrix/hybrid organization structure.

• Ability to troubleshoot and make quick knowledge and experience-guided decisions.

• Very good written and oral communication as well as strong presentation skills.

• Strong ability to plan and prioritize complex activities.

• Manage conflicting priorities with proactive resource planning and creative problem solving skills.

• Excellent people skills, ability to partner well, good team camaraderie.

• Proficient with Microsoft Office tools especially MS Word, MS Excel, MS PowerPoint, MS Project, and other management tools.

Thanks & Regards,

Pramod Sharma

Clinical/Pharma Recruiter

10 Exchange Place, Suite # 1820

Jersey City, NJ 07302

Direct No: 510-680-3022

Tel: (201) 524 9600 Ext 7291