[Hiring] Program Manager @Getinge

Role Description

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.

This is a defined term position for approximately 12-18 months, and fully remote in Eastern Standard Time.

Job Responsibilities and Essential Duties

• 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.
• 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.
• 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.
• 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.
• 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.

Qualifications

• 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.

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.

Benefits

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement