Sr Project Leader
About The Position
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. This role applies established project management and Agile best practices within a regulated medical device environment. In addition, the Project Leader serves as a team facilitator and mentor, promoting effective execution, continuous improvement, and consistent adherence to development processes and quality system expectations.
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.
- Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
Nice To Haves
- 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.
- Agile certification (e.g., CSM, PSM) and/or Project Management certification (PMP) preferred
Responsibilities
- 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.
Benefits
- medical and dental coverage that start on day one
- 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
- paid holidays
- paid time off ranging from 20 to 35 days based on length of service
- family and medical leaves of absence
- paid parental leave
- commuting benefits
- Employee Discount Program
- Employee Assistance Program (EAP)
- childcare benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
