Technical Program Manager (Medical Devices)
Plutus21
Descripcion del puesto
About the role
The Technical Program Manager coordinates the development of a medical device across hardware, optics, software, imaging, systems engineering, quality, regulatory, clinical and manufacturing workstreams. This full‑time remote role requires occasional travel to the US office.
Key responsibilities
- Maintain the integrated development plan, translate objectives into milestones, deliverables, owners, dependencies and target dates.
- Lead recurring meetings and milestone reviews, document decisions, maintain risk and action logs, and drive cross‑functional blockers to closure.
- Coordinate prototype builds, integration, software releases, test campaigns and clinical activities, managing materials, configurations and external bookings.
- Maintain development and released bills of materials, part numbers, revisions, quantities and supplier information.
- Coordinate approved engineering changes and assess impacts on schedules, suppliers, inventory and testing.
- Track stock quantities, locations, allocations, open orders and shortages, and work with on‑site staff on inventory records.
- Manage quotations, purchase requests, orders and supplier follow‑up within approved budgets, monitoring lead times and delivery commitments.
- Partner with engineering, quality and regulatory leads to maintain design and development records, coordinate design reviews and ensure traceability.
Required profile
- 5‑10 years of experience in technical program management, engineering operations or systems engineering.
- Degree in engineering, science or a related technical field preferred.
- Hands‑on experience with multidisciplinary hardware and software products, bills of materials, configuration and change control, inventory tracking and purchasing coordination.
- Strong technical fluency, communication skills and ability to lead technical discussions while respecting ownership.
- Highly organized, detail‑oriented and able to work independently in a remote setting.
Required skills
- Bills of Materials (BoM) management
- Configuration and change control
- Inventory tracking and material planning
- Purchasing coordination
- Program Management tools: Jira, Confluence, Smartsheet, Asana, Arena, OpenBOM
- Familiarity with design controls, design history files, ISO 13485, ISO 14971, IEC 62304, IEC 60601
- Experience with Class II medical devices and FDA‑regulated product development preferred
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Publicado hace 3 horas
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