Job Summary:

We are seeking a detail-oriented and technically experienced Healthcare Delivery Robotic R&D Product Development Manager to lead the development of autonomous mobile robotic (AMR) systems designed for healthcare environments (e.g., hospitals, labs, care facilities). This role requires hands-on leadership across system architecture, functional design, compliance (notably ISO 3691-4), and product commercialization. The ideal candidate will manage cross-functional engineering efforts, drive the creation of system/software requirements, ensure safety and risk compliance, lead testing and documentation, and work closely with commercial teams on customer and tender inquiries.

Key Responsibilities:

1. System & Software Requirements Management

• Lead the development and documentation of the Product System Requirements Specification (SRS) based on clinical, operational, and regulatory needs.

• Translate system requirements into detailed Product Software Requirements Specifications (SRSW).

• Ensure all requirements align with ISO 3691-4, and relevant healthcare robotics regulations and standards.

2. Functional Architecture & Design

• Define and maintain the functional architecture of the robotic delivery system, including control, perception, localization, navigation, and HMI subsystems.

• Collaborate with hardware, software, and safety engineers to design systems with high availability, modularity, and fault tolerance.

3. Risk Management

• Perform and document comprehensive risk assessments (ISO 14971), including hazard analysis, risk estimation, and mitigation.

• Conduct Failure Mode and Effects Analysis (FMEA) and ensure traceability of risks throughout the product lifecycle.

• Own safety concept development per ISO 3691-4 requirements for driverless vehicles in human-populated environments.

4. Testing & Verification

• Develop and execute the Product Test Plan, including unit, integration, verification, validation, and field-testing protocols.

• Oversee compliance testing and verification for navigation accuracy, load handling, obstacle avoidance, and safety zones.

• Ensure alignment with ISO 3691-4 testing procedures (e.g., performance under fault conditions, emergency stop behaviour).

5. Product Documentation & Release

• Lead creation of the Product Manual, including user instructions, safety guidance, maintenance procedures, and troubleshooting.

• Maintain document control for all design and development artifacts under ISO 9001.

6. Commercial Support & Tender Management

• Collaborate with commercial, sales, and tender teams to support technical documentation, product specifications, and customer responses.

• Assist with technical components of tender submissions, including compliance checklists, solution overviews, and integration requirements.

• Join customer calls or demo preparation to clarify system capabilities and safety features.

Qualifications:

• Bachelor's or Master's in Robotics, Mechatronics, Systems Engineering, or related technical discipline (PhD a plus).

• 7+ years of experience in robotic product development, with at least 3 years focused on mobile/AMR systems in healthcare or logistics.

• In-depth knowledge of ISO 3691-4, or similar functional safety standards.

• Demonstrated experience leading specification, architecture, risk assessment, and documentation in regulated environments.

• Proficiency with requirements management tools (e.g., DOORS, Polarion, Jama), CAD, and simulation environments (e.g., ROS/Gazebo, MATLAB/Simulink).

• Strong leadership, communication, and cross-functional collaboration skills.

Preferred Skills:

• Familiarity with hospital operations and delivery workflows (e.g., materials handling, pharmacy delivery, sterile services).

• Experience with AGVs/AMRs using SLAM, LiDAR, vision systems, and autonomous navigation stacks.

• Understanding of cybersecurity and interoperability in clinical IT networks (e.g., HL7, FHIR).