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Job Title:

Technical Project Manager

Position Overview:

As the Technical Project Manager (Engineer IV), you will serve as the primary architect of execution for high-priority medical device and robotics programs. This is a "player-coach" role requiring a "Systems Thinking" approach—managing the intersection of complex mechanical assemblies, embedded electronics, and sophisticated software stacks. You will lead cross-functional teams from concept through design transfer and global market launch, ensuring milestones satisfy both innovative goals and stringent regulatory mandates (ISO 13485).

· Strategic Planning: You will Lead Hardware-Software Integration (HSI) milestones, ensuring that hardware abstraction layers (HAL) and firmware APIs are defined early to prevent software development from being blocked by hardware lead times.

· Orchestrate Hybrid Lifecycles: Mapping Agile software sprints into a rigid Waterfall hardware schedule to ensure 'First-of-Kind' prototypes have functional code ready for bring-up.

· Technical Leadership: Resolving bottlenecks in mechatronics, firmware, and UI/UX.

· Governance: Ensuring the Design History File (DHF) reflects a cohesive, integrated system

Key Responsibilities:

Multidisciplinary Orchestration: Act as the Design Project Lead for Class I, II, and III medical & robotic devices. You must synchronize the development of physical hard-goods (orthopedics/implants), active hardware (robotics/sensors), and software (embedded systems/cloud).

Integrated Design Controls: Own the DHF. Ensure ISO: 13485 (Quality Management Systems) 62366 (Usability) & 62304 (Software Lifecycle) is seamlessly integrated with ISO 14971 (Risk Management) and IEC\ 60601 (Electrical Safety).

Technical Problem Solving: Transition fluidly between reviewing SolidWorks/Catia/Altium files and discussing API integrations or firmware architecture. You don't need to code, but you must lead the engineers who do.

V&V Strategy: Oversee Verification & Validation for integrated systems, ensuring that software updates don't compromise hardware safety and vice-versa.

Lifecycle & Tools: Maintain detailed Gantt charts for long-lead hardware components while managing Jira/GIT/Azure DevOps for iterative software tasks.

Stakeholder Translation: Translate robotic customers & clinical needs into high-performing technical specifications that both a Mechanical Engineer and a Software Developer can execute.

Qualifications:

Education & Experience

• Education: Bachelor’s degree in Biomedical, Mechanical, Electromechanical, Electrical, or Computer Science Engineering disciplines.

• Experience: 6+ years in engineering, with at least 4 years in a Systems-level Project Management role involving both physical products and software.

Technical Mastery

• Traceability Mapping: The proven experience to link high-level clinical/robotics user need to a specific software requirement and a physical hardware specification.

• Systems Fluency: Deep understanding of the Hardware-Software Interface (HSI); experience managing the release of firmware and software-controlled robotics.

• Design Controls: Expert knowledge of ISO13485, ISO14971, and specifically IEC62304 for medical device software.

• Tooling: Proficiency in CAD (SolidWorks/Catia), EDA (Altium/KiCad), and ALM/PLM software (Jira, Propel, Arena, or similar).

• Robotics: Experience with complex motion control, sensors (LiDAR/Vision/IMU), or humanoid actuation. Experience with IR-Cobot | AMR-AGV | Humanoid robotic systems, a plus

Project Rigor

• Hybrid Methodology: Ability to manage "Hard-goods" timelines (tooling, sterilization, lead times) alongside "Soft-goods" workflows (sprints, integration, regression testing)

Preferred Qualifications:

· Certification: PMP (Project Management Professional), CSM (Certified Scrum Master) or INCOSE System Engineering Professional is highly desired.

· Advanced Manufacturing: Experience in Additive Manufacturing (Metal/Polymer) and topology optimization (e.g., nTop).

· Regulatory Success: Specific experience obtaining Traditional or Special 510(k) registrations.

· Software Depth: Experience with Cybersecurity requirements for connected medical devices

· Cultural Fit: Thrives in a fast-paced, entrepreneurial "startup" environment; embodies values of accessibility, affordability, and empowerment.