Our global a high potential Medical Devcie start up developing cutting edge technologies to significantly advance healthcare and solve clinical needs are currently seeking an experienced, enthusiastic, and multidisciplinary Senior Technical Program Manager to join our highly skilled team. Reporting to the Senior Director of Operations, the Senior Program Manager will be responsible for leading the program core team in all aspects of execution to ensure delivery of all milestones within budget and successfully meeting all device development goals. As Senior Program Manager you will play a critical role in an early-stage startup environment and become part of a dynamic group of innovators, shaping the future of imaging in healthcare.


Role/Responsibilities:

• Provide Program leadership for highly complex device development.
• Identify resource needs, costs, program schedule, key milestones, scope, and report the progress to the established plan.
• Maintain and document development plans through product development cycle.
• Support DHF (Design History File) deliverable schedule with key stakeholders.
• Support design control process and meet Quality Management System requirements.
• Communicate with external vendors to set expectations, track risks, and ensure timely delivery to meet program goals.
• Lead teams to enable effective decisions and outcomes.
• Evaluate trade-off decisions and present actionable information to leadership stakeholders
• Manage program budget: functional expenses, capital requests, and forecasts.
• Prepare and report program performance to different levels of organization including senior leadership.

• Demonstrated expertise in leading and managing cross-functional multi-site teams to achieve program objectives in a matrix organization.
• Experience in functional areas: Hardware and Software Development, Quality, Medical, Commercial, Manufacturing Operations, Procurement, and Regulatory is preferred.
• Ability to evaluate and escalate changes that significantly impact the scope, timeline, or business goals or the program.
• Familiar with regulatory submissions and activities that lead to successful outcomes.
• Show history of influencing technical teams, driving efficient decision making, and leading team through complex problem solving.
• Use of metrics as indicators of potential roadblocks, risks, and issues which could block successful achievement of the program goals.
• Self-starter with good interpersonal and communication skills to break down complex issues and process into simplified and practical terms.
• Experience in using agile methodologies.
• Advanced knowledge and hands-on experience with MS Office, MS Teams, MS Project, SharePoint, JIRA, and Confluence.
• Bachelor’s degree in in Engineering, Biological Sciences, Business or related fields from an accredited college or university is required
• Master’s degree in in Engineering, Biological Sciences, Business or related fields from an accredited college or university is preferred
• 10+ years of experience in product development leading multi-site global programs in the Medical Device Industry or with equivalent design controls. Electro-mechanical experience, including software integration is preferred.
• PMP preferred
• Agile Certified Practitioner (ACP) a Plus