Program Manager - Systems

Primary Function of Position:
The Program is responsible for leading and executing the full product development lifecycle of medical device capital systems, from initial concept through commercial launch. This role requires deep expertise in medical device development, regulatory pathways, operations, and cross-functional project management. The Program Manager serves as a key driver of product innovation, compliance, and operational excellence within the organization. The Program Manager provides strategic leadership and tactical execution across all stages of product development, including concept generation, design, prototyping, verification and validation, regulatory submissions, manufacturing transfer, and launch. The role is pivotal in ensuring that all products meet stringent compliance requirements, including FDA, EU MDR, ISO standards, and relevant quality system regulations.
Roles & Responsibilities:
Strategic Leadership
Partner with product, technical, and functional leaders to shape program strategy, roadmap priorities, and execution plans.
Align engineering, clinical, operations, regulatory, and product teams to meet program and portfolio goals.
Facilitate program reviews and structured decisions to resolve issues, balance trade-offs, and maintain momentum.
Lead cross-functional negotiations, resolve root-cause disputes, and build sustainable stakeholder alignment.
Create concise executive narratives and reports that integrate analysis, recommendations, risks, and trade-offs.
Product & Design Development
Lead cross-functional teams through concept development, design iteration, prototyping, verification/validation, and design transfer to manufacturing.
Resolve cross-functional dependencies across subsystem teams, external partners, manufacturing, regulatory, and commercial functions.
Partner with design, clinical, human factors, and engineering teams to ensure product requirements, usability, and performance criteria are met.
Lead design control and business reviews, ensuring governance, compliance, accountability, and timely escalation.
Operational Execution
Drive manufacturing readiness, including process development, supply chain coordination, build readiness, and launch planning.
Ensure smooth transition from R&D to operations with strong cross-functional integration and documentation rigor.
Support ongoing product lifecycle, cost reductions, reliability improvements, and sustainment workstreams.
Partner with Finance to monitor program budgets, resource allocation, and long-term financial impacts.
Manage scope across projects, evaluating strategic alignment, delivery impact, dependencies, and trade-offs.
Optimize WBS and program schedules across interdependent projects, including critical and near-critical path analysis.
Regulatory & Compliance
Ensure project deliverables meet relevant US and global medical device standards and quality system requirements.
Coordinate cross-functional preparation of regulatory documentation and testing.
Champion strong design controls, risk management, and audit-ready documentation throughout the lifecycle.
Anticipate systemic regulatory, financial, operational, and technical risks; drive cross-functional response plans.
Skills, Experience, Education, & Training:
Required:
Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering or a related technical field; advanced degree preferred.
At least a minimum of 10 years' experience leading complex medical device development programs, including capital equipment or system-level products, from concept through commercial launch.
In-depth knowledge of medical device regulatory pathways (FDA, EU MDR, ISO 13485), submission requirements, and quality system regulations.
Proven ability to lead and influence cross-functional teams at multiple levels of the organization.
Experience collaborating with engineering, operations, regulatory, quality, and clinical teams throughout all development phases.
Exceptional communication and stakeholder-management skills.
Ability to handle ambiguity effectively and oversee multiple large projects at once
Advanced program planning skills, including WBS, dependency management, critical path analysis, scope control, risk management, and governance reporting.
Ability to coach peers on stakeholder engagement, communication, scheduling discipline, and program management tools.
Experience evaluating trade-offs across product features, customer needs, manufacturability, and cost.
Preferred:
Experience in robotic surgery, software/mechanical/electrical/optical technology based products and design transfer to manufacturing and service organizations.
PMP certification or formal project management training.
Familiarity with ALM/PLM systems, Agile methodologies, and project management tools.
Start-up experience a plus.

Employment type
Full-time

Work arrangement
No