Staff Operations Project Manager - New Product Industrialization

ZOLL Medical Corporation•Pittsburgh, PA

2d•$95,000 - $125,000

About The Position

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. ZOLL Cardiac Management Solutions offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes. On any given day, clinicians utilize these ZOLL products for tens of thousands of cardiac patients around the world: LifeVest, the world's first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death. HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent. TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. ZOLL has been Pittsburgh's Manufacturer of the Year, one of Western PA's Healthiest Employers, and even one of Pittsburgh's Coolest Offices. But it's our unique opportunity to impact people's lives that makes ZOLL the ideal place to build your career. The Staff Operations Project Manager serves as a strategic leader and the primary bridge between Product Development, Engineering, and Global Operations. This high-impact role will be responsible for orchestrating complex New Product Industrialization (NPI) programs and operational excellence initiatives from concept through mass production and lifecycle management. This role will also play a critical role in shaping project management methodologies and driving a culture of continuous improvement across the Operations organization.

Requirements

Bachelor’s Degree in Engineering, business, or a related field.
Project Management Certification (PMI CAPM or higher) and/or Certified practitioner of Lean Six Sigma or other CI methodologies a plus
5+ years of experience in project leadership/operations engineering
Proven success leading cross-functional teams through product launch and product lifecycle OR Experience with continuous improvement, process development, quality improvement, value engineering, and cost reduction
Highly effective leadership and communication abilities, with excellent interpersonal skills to build, motivate, and lead cross-functional teams, manage stakeholders, and collaborate with external partners as required.
Demonstrated track record of delivering results on complex projects.
Strong understanding of manufacturing processes, lean principles, industrialization processes, and/or supply chain dynamics
Proven ability to influence across all levels of the organization through relationship-building and management.
Excellent organizational, analytical, and problem-solving skills.
Demonstrated proficiency in data collection, analysis, and interpretation to drive root-cause identification, decision-making, and action.
High degree of creativity and comfort with ambiguity.
Ability to work independently to solve problems and make key decisions to ensure results without compromising on safety and quality standards.
Familiarity with project management tools (e.g. MS Project, Jira, Confluence, etc.)
Strong business acumen.

Nice To Haves

Experience managing portfolios/ initiatives and/or organizational transformation projects
Experience in launching products, process improvements, etc. across multiple facilities
Experience in waterfall, agile, or hybrid project management approaches
Knowledge of relevant FDA regulations (21 CFR, ISO 13485)
Familiarity with the use and integration of Operational Systems (ERP, MES, PLM, SCM) in complex environments
Strong understanding of Lean Six Sigma principles (e.g. DMAIC, VSM, etc.) and the effective application of each.
Knowledge/Familiarity with DFM/DFA concepts

Responsibilities

Develop detailed project plans outlining tasks, timelines, critical paths, and dependencies for key strategic initiatives.
Define and manage project scope to ensure successful delivery.
Proactively monitor and manage project budgets and capital expenditures (CapEx)
Develop and execute contingency plans for proactive mitigation of key project and business risks.
Standardize and maintain documentation and tools for project execution (e.g. schedules, performance metrics, dashboards), and champion execution standards for NPI and Operational Excellence projects.
Establish success criteria and monitor results after launch to ensure successful delivery of outcomes.
Build and leverage strong relationships across departments (R&D, Supply Chain, Quality, Regulatory, Support Services) to align goals and drive decisions.
Identify, assess, and collaborate with stakeholders to secure necessary staffing and resource requirements; assist in creating Operations-level objectives and capacity models as required.
Organize and facilitate business/technical project reviews and publish clear and concise updates for stakeholders at all levels.
Lead change management initiatives to accelerate the adoption of operational improvements and drive results in safety, quality, delivery, and cost.
Lead cross-functional teams through the execution of New Product Industrialization (NPI) and/or Continuous Improvement (CI) projects, ensuring alignment with business objectives.
Proactively identify and mitigate operational risks related to manufacturability, capacity, quality and supply chain readiness to ensure a smooth transition from design/development to launch.
Coordinate pilot builds, ramp-up activities, and production scaling while ensuring compliance with regulatory and quality standards (including post-market surveillance support).
Collaborate with leadership to capture lessons learned through effective post-mortem reviews to improve future project outcomes.
Own and maintain key operations deliverables through Stage-Gate and/or Product Development processes.