R&D Program Manager – Enterprise Software

This is a fully remote position, open to applicants in United States.

📋 Description

• Strategically plan, execute, and oversee Enterprise Software projects while adhering to strict deadlines and budget constraints.

• Oversee program risks, critical paths, costs, schedules, scope, resources, and multiple interconnected projects.

• Engage with resources and coordinate team members alongside third-party organizations to ensure project delivery aligns with established plans.

• Lead intricate software development programs for medical device products within regulated environments.

• Ensure adherence to FDA, ISO 13485, IEC 62304, cybersecurity, and Quality Management System requirements throughout the software development lifecycle.

• Manage programs that involve both on-premises and cloud-based software platforms, coordinating architecture, infrastructure, validation, deployment, and release activities.

• Analyze program risks, evaluate business impacts, devise mitigation strategies, and guide programs from inception to commercialization.

• Develop and implement project plans, modifying scope, schedules, and resources as necessary.

• Oversee daily program operations and ensure conformity with Stage-Gate processes, quality systems, and SOPs.

• Collaborate with Software Engineering, Quality, Regulatory Affairs, Cybersecurity, Product Management, Clinical, and Operations teams.

• Promote continuous improvement through Lean, Six Sigma, and other operational excellence methodologies.

• Establish and monitor program metrics, KPIs, and dashboards to track progress.

• Coordinate activities related to software verification, validation, traceability, documentation, and release readiness.

• Ensure that deployment, implementation, and commercialization plans effectively address customer-hosted and cloud-hosted environments.

• Spearhead process standardization initiatives and enhance workflow efficiency.

• Utilize project and portfolio management tools to maintain and communicate schedules, milestones, dependencies, and status updates.

• Create governance structures to ensure alignment, accountability, and effective decision-making.

• Maintain responsibility for Design History File deliverables, regulatory compliance, and QMS adherence.

• Document lessons learned and promote the adoption of best practices.

⛳️ Requirements

• A Bachelor's degree is required; a B.S. in Engineering, Computer Science, or a related technical discipline is preferred.

• A minimum of 7 years of Program or Project Management experience in leading complex software development initiatives within the medical device, digital health, or other regulated healthcare technology sectors.

• Demonstrated success in managing enterprise software development programs that support regulated medical device products; experience with Class II and/or Class III devices is preferred.

• Experience leading programs that involve both cloud-based (AWS, Azure, or GCP) and on-premises software deployments, releases, and lifecycle management.

• A strong understanding of the Software Development Lifecycle (SDLC), Agile methodologies, DevOps practices, software verification and validation, and cybersecurity requirements in regulated environments.

• Familiarity with FDA Quality System Regulations, IEC 62304, ISO 13485, ISO 14971, and other relevant medical device software standards is preferred.

• Knowledge of SaaS and connected medical device platforms is preferred.

• Lean Six Sigma certification (Green Belt or Black Belt) or proven experience in leading process improvement and operational excellence initiatives is preferred.

• Proven ability to lead and influence cross-functional teams, including Software Engineering, Quality Assurance, Regulatory Affairs, Product Management, Clinical, and Operations stakeholders.

• Exceptional communication, presentation, and stakeholder management skills, with experience in conveying program status, risks, and mitigation plans to senior leadership.

🏝️ Benefits

• 401(k) with a 6% employer match and no vesting period.

• Employee stock purchase plan.

• Flexible time off for salaried employees.

• Three to five weeks of vacation annually for hourly employees, depending on tenure.

• Up to 64 hours of paid sick time annually.

• Paid and/or floating holidays.

• Parental leave.

• Short- and long-term disability insurance.

• Tuition reimbursement.

• Health and welfare benefits.

• Discretionary annual bonus for non-sales positions.

• Potential eligibility for the Company’s long-term incentive plan.