Job Title: Medical Devices Program Manager
Unit: Surgical Research & Development
Location: Remote
Duration: 6-12 Months
Job Objectives / Purpose
Plan and oversee the allocation of resources and coordination of activities related to the development of surgical digital medical devices within Surgical R&D, utilizing the global Product Development Process (PDP), associated systems, and tools.
Key Activities / Responsibilities
- Lead Project Execution: Oversee the creation and execution of the project plan, work breakdown structure, timeline (MS Project), budget, and capital plan as needed. Adjust budget forecasts as necessary.
- Provide Expertise: Offer technical insight and project management proficiency to various program areas to ensure proper focus and progress.
- Project Leadership: Act as the program leader for ophthalmic digital medical device projects (including Cloud-based software and user applications).
- Collaborate with Stakeholders: Work closely with the Commercial team and key project members to gather Voice of Customer (VOC) insights for product design and development.
- Team Management: Oversee team activities using Agile software development methodologies such as Sprint and Scrum.
- Business Case Development: Partner with the Commercial team to develop business cases for new projects, including forecasts, cost estimates, pricing, and development expenses.
- Resource Coordination: Identify and negotiate functional resources to build an appropriate cross-functional project team.
- Risk Management: Create and maintain project and technical risk assessments. Identify risks, develop mitigation strategies, and manage risks to resolution.
- Effective Communication: Keep R&D management, Commercial, Quality, Regulatory, and other relevant functions informed of project status and aligned with project deliverables.
- Issue Escalation: Alert management promptly of any issues that may delay project timelines, enabling timely action. Propose solutions to minimize project impact.
- Design Compliance: Plan, coordinate, and conduct formal and informal project design reviews for compliance. Document design inputs, outputs, and verification.
- Ensure Quality Compliance: Ensure adherence to all current quality system requirements concerning design control.
Skills, Knowledge, and Abilities
- Program Management Experience: Experience in managing cloud-based medical device development is highly preferred.
- Familiarity with Cloud-based technologies
- Educational Background: Bachelor’s Degree in Engineering, preferably in Computer Science, IT, or a related engineering discipline.
- Certifications: PMP certification is desired.
- Advanced Qualifications: An advanced degree is a plus but not mandatory.