Robert Lerdahl, Pmp Email & Phone Number

Phoenix, Az, Us

Phoenix, Arizona

Provide project management support to more than 30 projects as part of Corrective Action Plan (CAP) and specifically the Quality System Improvement Program (QSIP) across the organization as part of remediation and continuous improvement initiatives including Validation, Labeling, Design Control, Process Optimization, Regulatory Compliance and Quality Assurance. Ensure timely execution by leveraging PMO tools, methods, best practices and lessons learned employing Plan-Do-Check-Act approach and a “3-2-1-Get it done” methodology resulting in operational consistency, organizational improvements and sustainability.  Provide support and oversight across numerous workstream CAPs to assure actions and milestones are on track while reporting key metrics to measure/monitor progress and status as well as resolution of issues and escalation as appropriate.  Lead the team through problem solving, process improvement and risk management activities. Collaboration with subsystem leaders, SMEs and process owners on short and long-term planning, developing work-structures to drive time-bound execution and promoting engagement by all stakeholders (People to Process to Procedure).

Phoenix, Arizona Area

Project Management support of high level virtual cross-functional team including Quality, Marketing, Packaging, Labeling, Planning, Production and Regulatory functions for multi-million dollar global rebranding project, encompassing over 1000 product SKUs and more than 20 product families. Highly complex project with constantly changing scope, priorities and risks (e.g. Brexit, MDR, EU Rep, Cannibalism/Inventory Planning). Creation and maintenance of overall project plan, including resource allocation, risk management, design control, quality and regulatory compliance, executive management reporting, team accountability and PMO governance. Assuring compliance with FDA Regulatory requirements, ISO Standards as well as new European Medical Device Regulation (EU MDR).

Phoenix, Arizona Area

Coordinate and execute strategic outreach initiatives to establish new corporate/agency partnerships. Identify sponsors’ needs and work with cross-functional leadership, including Communications, Program and Professional Development to develop action plans for ensuring their overall needs and requirements are met. Facilitate customer satisfaction by identifying inefficiencies and implementing process improvement as needed.

Phoenix, Arizona Area

Provided strategic leadership of program consisting of 50+ new product introduction (NPI) initiatives across 10 global manufacturing sites. Built, developed and led a team of 10 program managers (PMs), providing ongoing coaching and support to ensure the attainment of program goals. Held direct accountability for the full research and development (R&D) and product development life cycle, working with PMs through all related tasks. Partnered with cross-functional teams on strategic planning and implementing processes to drive continuous improvement. Led PMs through all project aspects, including identifying and mitigating internal and external customer risks related to technical, resource and budget issues, as well as quality issues and design non-conformances. Worked directly with PMs in assessing and identifying ever-changing customer requirements and revising project plans to meet aggressive deadlines. Managed strong cross-functional relationships with stakeholders and Manufacturing, Quality, Operations and Engineering teams to resolve resourcing challenges, scheduling conflicts and prioritization issues. Developed and implemented clearly defined program and departmental goals related to performance, quality and efficiency; delivered coaching and guidance for team members to ensure ongoing improvements. Created, integrated and implemented standardized templates for a robust NPI process, driving consistency across the entire program while simultaneously meeting corporate goals and objectives.

Cincinnati, Oh

Led cross-functional project teams through the development and launch of complex $MM electromechanical biopsy device system. Assessed customer requirements and developed project plan that aligned with Design Control & Risk Management procedures, as well as Quality System Regulations. Coached and supported 25+ team members through all project tasks to ensure optimal product development. Created and maintained all design control documentation, including reports, work instructions and SOPs. Facilitated daily project meetings to discuss project plans, changes, roadblocks and status, updating management, client and stakeholders on all potential issues. Conducted design reviews and design transfers through the full product development lifecycle. Prepared and tracked project schedule, budget and resources using MS Project and ProChain Critical Chain. Provided training for all team members in Visual Project Management and other tools. Developed and implemented PMO tools and templates to ensure consistency across all resources, coaching and training technical staff on project management best practices.

Ann Arbor, Mi

Functioned in a leadership role with direct accountability for managing the mitigation of System 1 Heart Lunch Machine and cdi 500 Blood Gas Monitoring NCRs related to system design, verification/validation testing, product complaints, vendor issues, design control documentation and manufacturing processes. Oversaw all project functions, including schedule development and managing, resources coordination and project planning. Coordinated and supervised project teams of up to 15 through all project functions, including risk management, design transfer and validation. Created design change plans, communicating all changes to project teams, clients and stakeholders. Led project team meetings, preparing and distributing agendas and minutes to inform team of all project plan revisions, roadblocks and status. Prepared and maintained reports and documentation, including work instructions and status reports. Conducted technical reviews and inspections on all products to ensure proper functionality.

Tempe, Az

Directed the planning and execution of numerous cross-functional percutaneous and endovascular/interventional project teams, including biopsy, PTA, Nitinol self-expanding stents, stent grafts and inferior vena cava filters. Facilitated the R&D of all products to ensure successful product launch, which included IDE, PMA, 510(k), NTF and CE Mark approvals in the US/EU/ROW. Managed project budgets ranging from $1M to $10M. Supervised and managed up to 5 direct reports. Managed end-to-end project tasks, including verification and validation testing, design transfers, root cause analysis, test method development, process qualifications and failure mode/effects analysis. Provided leadership and supervision for project teams of up to 15+, overseeing all related activities to ensure compliance with project specifications and quality requirements. Coordinated cross-functional teams consisting of Senior Quality, Marketing, Manufacturing, Regulatory and Clinical team members. Maintained all project documentation, including standard operating procedures (SOPs), inspection procedures, project plans, risk management documents (dFMEA/pFMEA, test methods and bill of materials (BOMs).Worked directly with customers, including physicians, nurses and clinical technicians to determine product requirements based on market need and user requirements. Identified new business opportunities and developed strategies for product development and launch. Planned and facilitated multiple GLP and non-GLP pre-clinical studies, handling all related tasks, including protocol development, execution, data analysis and final report writing. Submitted more than 25 invention disclosures, leading to 9 patent applications pending and 2 patents issued.

Austin, Texas Area

Recognized as resident polymers expert supporting and leading product projects teams through full R&D lifecycle from design to regulatory approval, production and launch. Instrumental in the development, testing and FDA approval of Durasul® highly crosslinked polyethylene and related products, as well as vendor qualification, clinical performance evaluations and marketing. Represented company at ASTM for standards and specifications development, including round-robin testing. Developed and implemented in-house explant retrieval program providing performance and design feedback to Product Development, Quality Assurance and Marketing teams.

Master Of Science - Ms, Biomedical Engineering (All Coursework Complete)

Bachelor Of Science - Bs, Biomedical Engineering

Activities and Societies: Varsity Soccer (4 year letterman and team captain); Psi Upsilon Fraternity