Program Manager - Systems

Description

The role leads the full product development lifecycle for medical device capital systems, from first concept through commercial launch.

The work calls for strong knowledge of medical device development, regulatory pathways, operations, and managing projects across functions.

The position drives product innovation, compliance, and operational quality, covering concept work, design, prototyping, verification and validation, regulatory submissions, manufacturing transfer, and launch.

The products must meet FDA, EU MDR, ISO, and quality system requirements.

Responsibilities

• Work with product, technical, and functional leaders to set program strategy, roadmap priorities, and execution plans.
• Get engineering, clinical, operations, regulatory, and product teams working toward program and portfolio goals.
• Run program reviews and structured decisions that resolve issues, weigh trade-offs, and keep work moving.
• Lead cross-functional negotiations, settle root-cause disagreements, and build stakeholder alignment that lasts.
• Write short executive reports and narratives that pull together analysis, recommendations, risks, and trade-offs.
• Lead cross-functional teams through concept, design iteration, prototyping, verification and validation, and transfer to manufacturing.
• Resolve dependencies between subsystem teams, outside partners, manufacturing, regulatory, and commercial groups.
• Work with design, clinical, human factors, and engineering teams to confirm requirements, usability, and performance criteria are met.
• Lead design control and business reviews that cover governance, compliance, accountability, and timely escalation.
• Drive manufacturing readiness, including process development, supply chain coordination, build readiness, and launch planning.
• Make the handover from R&D to operations smooth, with tight cross-functional integration and thorough documentation.
• Support the product lifecycle, including cost reduction, reliability improvements, and sustainment work.
• Work with Finance to track program budgets, resource allocation, and long-term financial effects.
• Manage scope across projects by weighing strategic fit, delivery impact, dependencies, and trade-offs.
• Optimize the WBS and schedules across interdependent projects, including critical and near-critical path analysis.
• Make sure project deliverables meet relevant US and global medical device standards and quality system requirements.
• Coordinate cross-functional work on regulatory documents and testing.
• Keep design controls, risk management, and audit-ready documentation strong throughout the lifecycle.
• Identify regulatory, financial, operational, and technical risks early and lead cross-functional response plans.

Requirements

• Required: A bachelor's degree in mechanical, electrical, or biomedical engineering, or a related technical field.
• Required: At least 10 years of experience leading complex medical device development programs, including capital equipment or system-level products, from concept through commercial launch.
• Required: Deep knowledge of medical device regulatory pathways (FDA, EU MDR, ISO 13485), submission requirements, and quality system regulations.
• Required: A record of leading and influencing cross-functional teams at many levels of an organization.
• Required: Experience working with engineering, operations, regulatory, quality, and clinical teams across all development phases.
• Required: Excellent communication and stakeholder management skills.
• Required: Comfort working through ambiguity while overseeing several large projects at once.
• Required: Strong program planning skills, including WBS, dependency management, critical path analysis, scope control, risk management, and governance reporting.
• Required: Ability to coach peers on stakeholder engagement, communication, scheduling discipline, and program management tools.
• Required: Experience weighing trade-offs across product features, customer needs, manufacturability, and cost.
• Preferred: An advanced degree.
• Preferred: Experience with robotic surgery, or with software, mechanical, electrical, or optical products, and with design transfer to manufacturing and service organizations.
• Preferred: PMP certification or formal project management training.
• Preferred: Familiarity with ALM/PLM systems, Agile methods, and project management tools.
• Preferred: Start-up experience.

Conditions

Some roles may require proof of current vaccination against certain diseases, including COVID-19; requirements vary by role.

Some roles may be subject to US export controls, so final offers may depend on an approved export license and/or a Technology Control Plan before the start date. Licensing can take 3 to 6+ months, and a Technology Control Plan typically adds 2 weeks.

Candidates who do not live, and do not plan to live, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee will be given preference.

The level may be set differently from the one listed, based on business need and the candidate's experience, knowledge, and skills. Pay depends mainly on the level filled and the candidate's qualifications, within legal limits.

Qualified applicants with arrest and conviction records are considered under fair chance laws.