Job Description & Skill Requirement:
Focus on having experience with Software Development Lifecycle in a regulated environment.
The software involves device software developed in C++ along with application and connectivity layers.
You will be responsible for driving software projects under medical devices domain.
Aware of ISO 13485 standards.
You will collaborate with team members, senior leaders, and stakeholders within the businesses, gaining agreements on and achieving project goals/objectives, balancing, and managing the project scope (including requirements), schedule, budget, quality, resources, and risks.
Responsible for project guidelines, scope and directives, to develop complete medical device change for products in the existing portfolio.
You will manage, schedule, cost, quality, requirements and keep abreast of developments in project management tools and processes, as well as technical domains. You will plan and monitor the program/projects activities, deliverables and budget during project execution, with an outcome-oriented view focused on maximizing the project benefits/business impact, all while appropriately balancing project risks, issue escalation and setting up detailed progress and escalation reports for the project steering team. You have a good understanding of medical documentation related to design controls, in a medical device environment. Understands the intent of the procedures to tailor the project deliverables (for project efficiency and effectiveness) without compromising compliance or quality. Bases the plan on the required decisions and not just on deliverables.
Qualification:
BE/B Tech
Any Graduate