Program Manager, Healthmark R&D (Defined Term)

Job Overview

The Program Manager is an execution focused individual contributor accountable for driving multiple concurrent, high priority projects within a single program to on time, compliant delivery. Operating within an FDA and ISO 13485 regulated environment, this role owns the integrated program view across Class I and II medical device development, sustainment, and remediation projects, managing cross project dependencies, shared resources, program level risk, and decision escalation. The Program Manager partners with Project Managers, functional leaders, and senior leadership to convert strategic priorities into executable plans, bringing structure, cadence, and clarity where they are still taking shape. Serving as a force multiplier for the program, this role accelerates momentum across workstreams, directly leads select projects as business needs require, and helps mature program management practices across Healthmark. This is a defined term position for approximately 12-18 months, and fully remote in Eastern Standard Time. 

Job Responsibilities and Essential Duties:

Program Leadership and Execution

• Own end to end execution of a program made up of multiple concurrent projects, delivering within approved scope, schedule, budget, and quality targets with limited supervision and strong ownership.
• Directly lead three or more projects within the program when required, while retaining accountability for overall program outcomes.
• Provide direction and day to day leadership to cross functional teams spanning R&D, Quality, Regulatory, Manufacturing, Supply Chain, and Lab functions through matrix relationships.
• Translate program objectives and loosely defined requirements into clear scope, deliverables, success metrics, and executable work plans.
• Drive accountability and follow through on commitments, action items, and decisions across all program workstreams.
• Ensure program deliverables are completed, documented, and released in compliance with design controls (21 CFR 820, ISO 13485) and internal procedures.
• Plan and lead program milestone reviews and confirm project readiness for design reviews, design freezes, V&V gates, and phase gate transitions.

Integrated Planning, Scheduling and Resource Management

• Build and maintain an integrated master schedule across all program projects, applying milestone and critical path methods to manage cross project dependencies and sequencing.
• Lead resource planning across the program, surface capacity constraints and conflicts between projects, and drive prioritization decisions with functional leaders.
• Develop and manage program budgets, estimates, and forecasts, monitoring performance against plan and driving corrective action.
• Implement plan changes within approved program boundaries and bring recommendations forward for decision when changes exceed them.

Risk, Issue and Dependency Management 

• Ensure technical, regulatory, schedule, and resource risks are identified, assessed, and mitigated at both the project and program level, consistent with ISO 14971 risk management principles.
• Analyze risk trends across projects to identify systemic issues and develop program level mitigation strategies.
• Maintain program risk registers, issue logs, and decision logs, with clear escalation pathways so blockers are resolved quickly.
• Develop alternative scenarios and recovery plans to protect critical milestones.

Governance, Reporting and Stakeholder Communication

• Establish and run the program operating cadence, including program reviews, decision forums, and cross functional team meetings.
• Assemble and report program metrics covering scope, schedule, budget, risk, quality, and compliance, and make them readily accessible to project teams and stakeholders.
• Communicate program status, milestones, risks, and recommendations to senior leadership through concise executive level reporting that drives timely decisions.
• Maintain effective working relationships with local and global Getinge stakeholders, keeping program execution aligned with business priorities.
• Coordinate program inputs to regulatory submissions (510(k), De Novo) and quality system activities as required.

PMO Capability Building

• Contribute to the design and deployment of PMO processes, templates, tools, and governance standards, applying lessons learned from the program to strengthen enterprise practices.
• Coach and mentor Project Managers and cross functional team members on program management methods and PMO tools.
• Identify and champion improvements that increase execution speed, predictability, and cross functional alignment.

Required Knowledge, Skills and Abilities:

• Demonstrated success leading multiple concurrent, complex projects or a program through a structured phase gate process in a regulated environment.
• Proven ability to drive execution and deliver results where processes, roles, and priorities are still being defined.
• Thorough understanding of Medical Device Quality Management Systems (ISO 13485, 21 CFR 820, ISO 14971), design controls, V&V processes, and FDA Class I/II device requirements.
• Working knowledge of FDA and international standards requirements as related to capital equipment and disposables.
• Advanced proficiency with Microsoft Project or equivalent tools, including integrated scheduling, critical path analysis, and resource loading.
• Strong financial acumen for program budgeting, forecasting, and tracking.
• Ability to lead and influence cross functional teams and senior stakeholders without direct authority.
• Executive level written and verbal communication skills, with the ability to distill complex program information into clear decisions and recommendations.
• Skilled facilitator of technical and decision making meetings with both technical and non technical audiences.
• Highly organized and detail oriented, with a bias for action and a strong sense of ownership.

Minimum Requirements:

• Bachelor’s degree in an Engineering discipline (e.g., Systems, Biomedical, Mechanical, Electrical or Software Engineering) or related field.
• 8+ years’ experience leading complex NPD, sustainment, business, commercial, or operations projects/programs in the medical device industry.
• Strong understanding of design controls, V&V processes, and FDA Class I/II device requirements
• Demonstrated experience leading multiple concurrent projects or a program under FDA design controls and ISO 13485.
• PMP or PgMP certification required.

Environmental/Safety/Physical Work Conditions: 

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
• Office or production environment.
• May work extended hours during peak business cycles.
• Domestic and international travel up to 25%.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.