Generis Tek Inc · 8 hours ago
R&D Engineer Project Manager II
Santa Clara, CA
Full-time
Onsite
Mid Level
$46/hr - $46/hr
3+ years expGeneris Tek Inc is a boutique IT/professional staffing company based in Chicago land, seeking an R&D Engineer Project Manager II. The role involves managing project scope, leading cross-functional teams, and ensuring compliance with FDA regulations while delivering projects on time and within budget constraints.
Information Technology & Services
Responsibilities
Experience/familiar with supplier process validation and FDA regulations (ISO 9001 and 13485)
Comprehensive knowledge of medical device design controls and Quality Management Systems
Experience with design and implementation of Project Development Plans including scope, scheduling, and resourcing
Lead Meetings with external suppliers and internal cross functional teams and Keep/distribute meeting notes capturing key discussion points/decisions made/action items
Drive teams to meet milestones and deliverables established in project planning and agreed upon with senior leadership
Recognize and integrate the broader implications of actions and proposals on the final project outcomes
Accountable for clearly defining and managing total project scope; develop and manage project charter and project plan to meet deliverables. Identify key milestones for project status reporting; complete projects on time and within budget constraints
Manage creation and updates of detailed project plans, resource and budget management, schedule management, project risk assessments, and project documentation
Lead cross-functional teams to execute projects, identifying tasks, creating and tracking project schedule with problem solving methodology; identify problems and work with cross-functional team to resolve them
Using advanced excel skills and PowerBI, prepare and present data-informed written and oral reports and other presentations to sr. leadership audiences; under supervision, may create and deliver project review presentation to leadership as necessary
Track and present budget variances, and recommend contingency options
Create a work environment that supports team effectiveness
Qualification
Required
3-6 yrs in a FDA regulated industry
Experience/familiar with supplier process validation and FDA regulations (ISO 9001 and 13485)
Comprehensive knowledge of medical device design controls and Quality Management Systems
Experience with design and implementation of Project Development Plans including scope, scheduling, and resourcing
Lead Meetings with external suppliers and internal cross functional teams and Keep/distribute meeting notes capturing key discussion points/decisions made/action items
Drive teams to meet milestones and deliverables established in project planning and agreed upon with senior leadership
Recognize and integrate the broader implications of actions and proposals on the final project outcomes
Accountable for clearly defining and managing total project scope; develop and manage project charter and project plan to meet deliverables
Identify key milestones for project status reporting; complete projects on time and within budget constraints
Manage creation and updates of detailed project plans, resource and budget management, schedule management, project risk assessments, and project documentation
Lead cross-functional teams to execute projects, identifying tasks, creating and tracking project schedule with problem solving methodology; identify problems and work with cross-functional team to resolve them
Using advanced excel skills and PowerBI, prepare and present data-informed written and oral reports and other presentations to sr. leadership audiences; under supervision, may create and deliver project review presentation to leadership as necessary
Track and present budget variances, and recommend contingency options
Create a work environment that supports team effectiveness
Company
Generis Tek Inc
Generís Tek is an elite IT staffing firm headquartered in Chicago, IL offering long-term, short-term, temporary-to-permanent and direct placement staffing.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase