ZOLL Cardiac Management Solutions · 1 day ago
Staff Operations Project Manager - New Product Industrialization
Pittsburgh, PA
Full-time
Onsite
Senior Level, Lead/Staff
$95K/yr - $125K/yr
5+ years expZOLL Cardiac Management Solutions is dedicated to improving patient outcomes through innovative technologies in the medical field. The Staff Operations Project Manager will lead New Product Industrialization programs and operational excellence initiatives, ensuring effective project management and collaboration across departments to enhance product delivery and quality standards.
Medical Device
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
Qualification
Required
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
Preferred
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
Company
ZOLL Cardiac Management Solutions
ZOLL Cardiac Management Solutions (CMS), a division of ZOLL Medical Corporation, offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes in cardiac patient care.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase