MediView is building the future of surgical guidance and navigation with Augmented Reality (AR) and Artificial Intelligence (AI). MediView is seeking a Technical Program Manager who thrives in highly technical, cross-functional environments and knows how to drive complex medical technology programs from concept through production release. This is not a traditional program management role. This role is for an execution-focused systems leader who can build trust across engineering, quality, regulatory, manufacturing, and commercial teams, while driving clarity, accountability, rigor, and delivery across the organization. This individual will serve as the operational CEO of product development execution.

This position requires an individual that is highly technical, deeply organized, emotionally intelligent, and can own execution across the full lifecycle of complex HW/SW/AI medical device systems. The ideal person for this position will:

• Understand how integrated systems actually work
• Connect user needs all the way through design transfer
• Decompose ambiguity into executable plans
• Know how design changes ripple through engineering, quality, regulatory, manufacturing, and commercialization
• Build trust by understanding the details, asking the right questions, and helping teams succeed
• Drive accountability without formal authority
• Create clarity in fast-moving and ambiguous environments
• Operate with extreme ownership

This person will also be comfortable:

• Reviewing a systems architecture discussion
• Driving FDA design control execution
• Challenging schedule assumptions
• Leading risk reviews
• Managing cross-functional dependencies
• Working through manufacturing readiness
• Identifying gaps in requirements traceability
• Helping teams get releases across the finish line

This role requires both strategic leadership and tactical execution excellence.

DUTIES AND RESPONSIBILITIES:

End-to-End Program Execution

• Own execution of complex medical device development programs from concept through commercial release and production scaling
• Lead integrated HW/SW/AI/system-level program planning and execution
• Build and maintain fully integrated cross-functional schedules with clear dependencies, critical paths, risks, and execution gates
• Drive disciplined execution across engineering, regulatory, quality, clinical, operations, manufacturing, and commercial functions
• Ensure programs execute within scope, timeline, budget, and quality objectives.

Cross-Functional Leadership

• Lead matrixed cross-functional teams without direct reporting authority
• Build trust, alignment, accountability, and execution momentum across the organization
• Create operational clarity in fast-moving and ambiguous environments
• Facilitate difficult technical and organizational conversations with credibility and composure
• Drive teams towards decisions while balancing technical risk, clinical usability, regulatory requirements, and business priorities

Systems-Level Thinking

• Develop deep understanding of the complete product ecosystem:
• Hardware
• Software
• AI/algorithms
• Data pipelines
• Cloud and infrastructure
• Clinical workflows
• Manufacturing systems
• Integration points
• User experience
• Regulatory requirements
• Understand how component-level decisions impact the overall system
• Identify integration risks early and proactively drive mitigation plans

FDA Design Controls & Quality Execution

• Lead execution within FDA and ISO 13485 design control frameworks
• Ensure complete and high-quality traceability from:
• User Needs
• Intended Use
• System Requirements
• Subsystem Requirements
• Design Inputs
• Verification
• Validation
• Risk Controls
• Design Transfer
• Drive phase gate readiness and DHF completeness
• Ensure design changes are properly assessed across:
• Engineering
• Clinical
• Commercial impacts

Risk Management & Operational Rigor

• Lead program-level risk identification, escalation, mitigation, and contingency planning
• Challenge assumptions and uncover hidden execution risks
• Drive proactive issues resolution rather than reactive firefighting
• Break large programs into executable workstreams and component-level deliverables
• Ensure teams are operating from realistic plans, clear ownership, and measurable deliverables
• Drive disciplined change management and impact assessment

Program Infrastructure & Operational Excellence

• Build scalable program management systems, tools, and operating rhythms
• Develop integrated dashboards, metrics, schedules, and execution frameworks
• Lead resource planning and dependency management
• Improve organizational execution maturity and operational rigor
• Implement best practices for technical program management in regulated product development

Perform all other duties as assigned.

WHAT SUCCESS LOOKS LIKE

The right person for this role will:

• Become the organizational center of gravity for execution
• Build confidence and trust across the company
• Create alignment across highly technical teams
• Bring order and predictability to complex development efforts
• Increase execution speed without sacrificing quality
• Anticipate issues before they become crises
• Successfully drive products through development, verification, validation, design transfer, and production release
• Help transform MediView into a world-class product development organization

QUALIFICATIONS/EXPERIENCE:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education:

• Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, Systems Engineering, or a related field.
• Advanced degree preferred.
• PMP certification preferred but not required if equivalent real-world execution experience is demonstrated.

Required Experience:

• 10+ years leading highly technical, cross-functional product development programs
• Proven success delivering complex medical devices from concept through commercialization
• Strong experience leading integrated hardware + software systems programs
• Deep understanding of FDA design controls and regulated product development
• Experience with:
• ISO 13485
• IEC 62304
• Risk management processes
• DHF management
• Verification & validation planning
• Design transfer
• Demonstrated ability to lead matrix organizations without direct authority
• Proven ability to recover struggling programs and drive execution discipline
• Experience operating in startup or high-growth environments with ambiguity and rapid change
• Strong technical fluency across software, hardware, systems engineering, and data/AI-enabled products

Ideal Background:

Strong candidates may come from environments such as:

• Surgical robotics
• Image-guided therapy
• Navigation systems
• AR/VR medical platforms
• Robotics
• Aerospace systems
• Defense systems
• Autonomous systems
• Complex regulated HW/SW platforms

Required Capabilities:

Technical & Systems Acumen

• Ability to understand deeply technical discussions across multiple disciplines
• Strong systems engineering mindset
• Ability to connect architecture decisions to execution risk
• Ability to identify gaps, dependencies, and integration issues early

Program Leadership

• Exceptional program planning and execution skills
• Expert-level schedule development and critical path management
• Advanced risk management capabilities
• Ability to manage multiple large-scale concurrent programs

Communication & Influence

• Exceptional communication skills across executive leadership and technical teams
• High emotional intelligence and organizational awareness
• Ability to build trust quickly with engineers and cross-functional stakeholders
• Strong facilitation, negotiation, and conflict resolution skills
• Comfortable holding teams accountable while maintaining strong relationships

Personal Characteristics

• Relentlessly organized
• Systems-oriented
• Technically curious
• Highly accountable
• Detail obsessed
• Calm under pressure
• Direct and transparent
• Operationally rigorous
• Intellectually honest
• Proactive rather than reactive
• Hands-on and willing to dive into the details
• Respected because they understand the work, not because of title

PHYSICAL DEMANDS:

While performing the duties of this job, the individual must be able to remain in a stationary position for 90% of the time while operating their computer and performing office work. The individual needs to occasionally move about inside the office. They must be able to exchange accurate information with customers and others in the office while interacting. The employee must regularly lift and/or move up to 15 pounds, occasionally lift and/or move up to 30 pounds.

WORK ENVIRONMENT:

While performing the duties of this job, the individual is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually low to moderate. The individual frequently works in a controlled climate. May be in clinical or hospital environments where health may be at risk due to exposure from patients that may have infectious diseases.

IMPORTANT NOTE:

This role requires deep engagement with the team, the technology, and the product development process.

We are not looking for a status-reporting project manager.

We are looking for a technical execution leader who can help drive world-class product development and deliver breakthrough medical technology to market.

30-40% travel requirement