Project Management Director

THE ALFRED E MANN FOUNDATION FOR SCIENTIFIC R•Santa Clarita, CA

About The Position

The Project Management Director leads one or more complex, cross-functional development programs from moderate to Class III medical devices that include mechanical, hardware, software, and firmware sub-systems. This role is accountable for end-to-end program and/or project planning, execution, monitoring, and risk mitigating across the product lifecycle—from concept and feasibility through design, verification/validation, regulatory, and pre-clinical/clinical study support—while ensuring alignment to FDA Quality System Regulation expectations (including design controls) and relevant TÜV/ISO-based conformity assessment pathways. The role partners closely with Program/Project Business Leads, R&D, Systems Engineering, Quality, Regulatory Affairs, Clinical, Operations, and strategic suppliers to drive on-time delivery, technical integration, risk management, and product life cycle documentation per HMT standard operating procedures. The Project Management Director will help to drive technical project management standards that drive efficiency while driving compliance to HMT development practices.

Requirements

Lead low and high complexity cross-functional projects and programs including business systems and strategic supplier engagements
Operate independently in managing core team, middle and senior management needs
Build integrated master schedules that support managing dependency logic, critical path, and trade-off decision based on scope, risk, cost and timeline
Drive program and project level decision making to meet or exceed milestone needs
Support audits by working teams to ensure program documentation assets are complete, consistent and traceable
Manage supplier-driven schedules and risks while translating technical complexity into actionable plans and communicate concisely
Integrate product requirements and scope on Business Lead input to meet market needs in a timely manner.
Develop, maintain, and distribute (as appropriate) standard project management deliverables for the successful launch of new products and services, including implementation plan, project schedule, project budget and variances, issues & action items reports, meeting minutes, risks assessment and contingencies.
Influence the cross-functional team, middle management and senior levels to drive program success and delivery
Ability to work and drive change in an enterprise environment
Hands on approach to program management in the definition, planning, execution and delivery of products and processes.
Bachelors degree in a technical field, preferably Engineering based (Systems, Software, Electrical, Biomedical Engineering), an Advanced Degree (M.S., MBA) is preferred
Project Management Professional (PMP) certification preferred (or equivalent demonstrated program leadership capability).
Knowledge and experience with full product development life cycle including exit strategies
Experience leading hardware/software/firmware development within regulated product development (including requirements, verification planning, release management, and integration testing)
Successful track record working with the FDA/TUV regulations and Quality Systems
7+ years of progressive functional experience in an engineering leadership capacity driving mechanical, hardware, or systems verification teams
15+ years experience managing and/or directing technology and product development efforts
15+ years experience working in the medical device industry and/or related or similar high technology/regulated industry
Strong Systems level thinking across all functional groups
Experience leading teams, projects and programs within a portfolio

Nice To Haves

An Advanced Degree (M.S., MBA) is preferred
Project Management Professional (PMP) certification preferred (or equivalent demonstrated program leadership capability).

Responsibilities

Own the Integrated project plan and drive the execution across multiple workstreams as defined by the Program Charter
Ensure scope, schedule, budget, resources, and dependencies are captured and actively managed and transparently communicated.
Drive program/projects governance (core team cadence, design reviews, phase-gate readiness), define measurable milestones, and maintain decision logs, action tracking, and escalation pathways to remove blockers quickly
Coordinate systems integration activities such as interface definition, integration builds, end-to-end verification planning, and readiness for system verification and validation, ensuring traceability from user needs to design inputs/outputs and test evidence.
Lead cross-discipline planning and delivery for system-level integration of product requirements
Ensure the program operates within a compliant product development framework consistent with regulated design controls and applicable standards expectations, partnering with Quality/Regulatory/Clinical to drive DHF deliverables, requirements traceability, program risk management alignment, technical and design review rigor
Facilitate design reviews with the cross-functional team, ensure objective evidence is captured, and confirm that verification/validation, usability activities (as applicable), and pre-clinical readiness are planned and executed.
Drive program-level risk management, integrating technical, schedule, supplier, quality, and regulatory risks into a single risk view, driving mitigation plans and contingency triggers
Proactively manage change control across requirements, architecture, and release content, aligning stakeholders on impact assessments and ensuring controlled execution
Integrate supplier deliverables critical to the project success (e.g., contract manufacturers, software vendors, component suppliers, test partners), including statements of work, schedules, quality expectations.
Facilitate supplier readiness with program technical leads to meet incoming quality expectations, and change notifications, ensuring supplier activities align with program milestones and compliance needs
Provide clear, executive-ready reporting on program health, including milestone progress, critical path, resource constraints, risk posture, quality/regulatory readiness, and key decisions required
Contribute to continuous improvement of product development and program/project management processes, templates, and governance practices in regulated environments
Supports best practice implementation for program delivery across the organization
Influences the organization with tools, methodologies that drive efficient product development and quick turn delivery.