Program Manager (Medical Device)

Job Summary
The Program Manager is responsible for planning, managing, and executing complex, multi-device product development projects in alignment with applicable standard operating procedures. This role leads cross-functional teams—including product development, quality, manufacturing, and procurement—from concept through commercialization as defined by customer agreements.

Essential Functions

• Manage a portfolio of complex projects spanning one or multiple business lines.

• Provide on-site leadership, motivating teams to meet goals, responsibilities, and milestones.

• Own full project life cycle; ensure delivery meets or exceeds customer expectations.

• Track and report on project metrics, milestones, testing, and deployment activities.

• Work collaboratively and analytically to support a high-performance, solutions-focused environment.

• Contribute to the development of organizational practices, templates, policies, tools, and partnerships.

• Support project estimation and develop detailed plans for all project phases.

• Secure and manage resources necessary to meet project objectives and timelines.

• Communicate project status, milestones, risks, and issues to leadership.

• Understand and align solutions with customer goals and industry best practices.

• Manage scope, change control, and project documentation.

• Oversee ongoing quality control and support resolution of quality issues.

• Define Statements of Work and product/service specifications.

• Manage all aspects of project and program engagement, including planning, vendor relationships, communication, budgeting, change management, risk, and issue tracking.

• Provide progress updates to stakeholders.

• Coach, mentor, and supervise project team members.

• Ensure adherence to scope, schedule, budget, and quality standards.

• Support internal functions such as finance, accounting, HR, and quality to ensure compliance.

Requirements

Education & Experience

• Bachelor’s degree in a scientific or technical field; 10+ years of experience in a regulated industry (e.g., pharmaceuticals or medical devices).

• Minimum 10 years of project management experience in a regulated environment.

Skills & Competencies

• Ability to manage confidential and sensitive information.

• Comfortable in a fast-paced, dynamic environment.

• Strong organizational skills; able to manage multiple projects simultaneously.

• Effective under pressure with strong problem-solving abilities.