Allison Frey Email & Phone Number

United States

Orange County, California, United States

- Responsible for a team of 4 direct reports (build new team PMO and engineering, recruit, train, mentor, supervise, evaluate), organizational strategy, project funnel, resource allocation and project prioritization. Manage and develop resources to achieve new product development, sustainment, and regulatory goals through design control process stages and gates.- Manage and be accountable for product development, commercialization, technology transfer and market expansion activities across organizational departments, cooperatives and teams (R&D, Quality, Manufacturing, Marketing, Clinical, Regulatory and Supply Chain, etc.). Builds and maintains team member and stakeholder relationships, expectations and communications.- EU MDR MDD & Global Re-Registration: responsible for strategy, prioritization, planning, coordination, resources, project/program management, budget targets and reporting. Responsible for coordination of global multi-site cross-functional teams for regulatory updates (labeling, drawings, V&V, IFU, biocompatibility), deployments (ECO/ECR/discrepancies), and inventory transitions (step-in/step-out) for new revisions . All these were coordinated with corresponding audits of technical documentation including sales forecasts and global in-country bridge inventory.- Mentoring (Project/Cluster/Portfolio Subject Matter Experts) : Select, hire, onboard and mentor 100% of the PMO team (DBS, PSP, VPM, Visual Project Management, Lean, Shingijutsu, Kaizen, Seminar, Gemba). Develop talent development and succession plans. Personally drive global cross-functional teams (meetings, agendas, milestones, best practices, minutes, action items, critical path ......)

Orange County, California, United States

Torrance, California, United States

• From Concept to Market (E2E): Functional, Technical, and Project / Program Leader bringing new diagnostic platforms (FDA Class 2, Released in 3yrs, including FDA 510K approval) +10MM/year initial market. • Management: The scope of my activities reaches FDA 510K submissions and their direct hands on support, including (but not limited to) design control, design history file, requirements definition, research, development, verification, validation, schedules, milestones, budgets (NPI, AOP, Forecast, NPV analysis, P&L implementation, and cost improvement projects…), options & negotiation, stage gate meetings & approvals, vendors & contractors management, testing (internal external laboratories), quality assurance & regulatory compliance (FDA CFR 21 part 820, IEC 60601, ISO 13485…), risk analysis, risk management, reliability, key stakeholders interface (Executives, Product Managers, Customer Support, Service…), production lines (design, setup, automation, improvement, updating) and continuous improvement process initiatives (CIP, Kaizen, Lean Six Sigma Green Belt LSSGB).• Portfolio Management: Responsible for Source, Built, Lead, Mentor, Guide, and Program Project Management (PMO) of Global Cross-Functional teams for Research and Development (R&D). • New Product Introductions and Sustaining Engineering: Accountable for new and existing products throughout their life cycle (Medical Devices FDA Class II), by the direction of subordinates (full time, contractors, and OEMs) and or from the front line (hands-on, mentoring)

Orange County, California, United States

Manage the New Product Development (NPD) projects from inception to release (Program Manager, Project Manager, PMO). Own the NPD development process and work with manufacturing, quality, and engineering to ensure that the process complies with the quality system and FDA regulations (Medical Devices, FDA Class II). Own and maintain the device’s master records. Create, setup, and update production lines, manufacturing processes, and test procedures. Lead risk analysis, Failure Mode and Effects Analysis (FMEA), Kaizen (Lean Six Sigma) and continuous improvement activities