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The Sr Project Leader will lead cross-functional teams in the execution of Medical Device software and/or medical device hardware new product development projects. This role is responsible for coordinating all aspects of assigned projects, engaging appropriate functional partners to drive progress, resolve issues, and implement corrective actions as needed. The Project Leader establishes strong working relationships and credibility with team members and stakeholders while ensuring project deliverables meet schedule, cost, quality, and regulatory requirements.
Job Responsibility
Lead cross-functional, multidisciplinary teams—potentially including globally distributed resources—in the development of Software and/or medical device hardware products
Plan and execute projects in alignment with New Product Development (NPD), Design Control, and Quality Management System requirements
Collaborate with software, systems, hardware engineering, quality, regulatory, manufacturing, and supply chain partners to develop and maintain integrated project plans
Facilitate tasks, responsibilities, and accountability to team members to achieve project and product objectives
Facilitate Agile Scrum processes for projects, including sprint planning, daily standups, sprint reviews, and retrospectives, while ensuring alignment with regulated development practices
Drive achievement of project milestones related to quality, time-to-market, cost, and regulatory compliance
Track and manage project budgets, including labor, operating expenses, and capital expenditures
Monitor project status, risks, and dependencies
apply appropriate change management practices to evaluate and address schedule, scope, or resource variances
Coordinate and support assessments of scope changes and their impact to quality, regulatory, cost, and schedule commitments
Communicate project status, risks, and escalation topics effectively to functional leaders and management
Contribute to team development by sharing best practices, supporting less-experienced team members, and fostering a culture of accountability and continuous improvement
Requirements
Proven project management experience leading cross-functional teams in product development environments
Experience supporting software-intensive products, SaMD, and/or regulated medical device hardware development
Working knowledge of Agile Scrum principles and the ability to facilitate Scrum ceremonies within a regulated environment
Understanding of medical device development regulations and standards (e.g., FDA design controls, ISO 13485, IEC 62304, ISO 14971), or experience in other highly regulated industries
Demonstrated ability to influence team members, manage priorities, and drive execution against challenging timelines
Strong interpersonal and communication skills with the ability to engage diverse technical and functional stakeholders
Solid business acumen with experience managing project budgets, resources, and trade-off decisions
4+ years of experience in project management or leading new product development teams, including coordination with external partners or suppliers
Bachelor's degree in a technical discipline required
Experience in one or more of the following areas is preferred: software development, systems engineering, electronics, mechanical design, injection-molded plastics, requirements management, verification and validation, or testing
Experience in one or more of the following areas is preferred: software development, systems engineering, electronics, mechanical design, injection-molded plastics, requirements management, verification and validation, or testing
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave