Nityo Infotech Corporation
Pittsburgh, PA
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Job Description :
Title: Project Manager with Medical device Experience
Location: Warsaw, IN
Duration: Full time



Relevant Experience (in Yrs) 5+ years

Technical/Functional Skills

This profile will require the candidate identified to work in New Product Development in Medical Devices. The candidate MUST have Project Management experience in Medical Device. The candidate should also be experienced in medical product development – specifically function & design requirements, design verification test, risk analysis, basic regulatory pathways, design History File creation.

Experience Required

Exposure to Project Management in Medical Devices
Knowledge of using Project Management and Program Management tools and concepts
PMP or equivalent certification is an advantage
Exposure to design & development of medical devices
Medical device risk assessment techniques, design failure mode effect analysis (DFMEA)
Exposure to Product Development Documentation
Knowledge in Design History File (DHF) creation.
Exposure to verification and validation activities
Design Quality experience
Orthopaedic and Spine Product knowledge will be an advantage

Roles & Responsibilities
Project management to manage and track overall product development
Drafting various aspects of DHF
Manage Design Control Plan
Manage Device test plan, write design verification test protocol, test report
Perform Design Risk Management and DFMEA
Interact with all functional groups involved in product development process – Manufacturing, Design Quality, Marketing, External Supplier etc.

Generic Managerial Skills

Highly developed negotiation and influencing skills
Highly developed and proven written and oral communication skills
Knowledge in Project Management and Program Management concepts and tools
Organizational / planning skills
Strong analytical skills
Comfortable with using and facilitating a variety of problem solving methodologies
Mentors and develops junior staff within the TCS delivery organization
Willing to work with offshore teams in remote locations

Work Location : Warsaw, IN
             

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