Senior Project Manager responsible for software project management in medical device development. Overseeing risks, resources, and timelines to ensure successful project delivery.
Responsibilities
Plan, execute, manage risk, manage critical path, and commercialize software projects according to strict deadlines and within budget
Engage resources and coordinate the efforts of team members, third-party organizations, and clients to deliver projects according to plan
Create project team governance to engage cross-functional accountability of costs, schedules, scope, resources, and track risks of projects
Analyze project risks and identify their impact while developing mitigation strategies
Ensure appropriate project level definition across all stakeholders and manage the project from concept to commercialization
Manage day-to-day operational aspects of a project and scope
Comply with the Stage Gate Process quality system and help enforce standard operating procedures (SOPs)
Mitigate team conflict and communication problems
Motivate team to work together in the most efficient manner
Own and create appropriate levels of governance to ensure alignment and clear objectives
Accountable for product compliance to design history file, regulatory standards, and QMS procedures
Requirements
5 plus years of project management experience leading medical device development
Experience with medical device development under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems
Technical project management in software product development
Benefits
401(k) with up to a 6% employer match and no vesting period
Employee stock purchase plan
Flexible time off for salaried employees
Accrual of three to five weeks’ vacation annually for hourly employees (based on tenure)
Accrual of up to 64 hours of paid sick time annually
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