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Willow Laboratories · 1 day ago

Engineering Project Manager

Irvine, CA

Full-time

Onsite

Senior Level

$130K/yr - $170K/yr

5+ years exp

Willow Laboratories is seeking an experienced Engineering Project Manager with medical device experience who thrives in a startup or high-growth environment. The role involves leading complex product development programs, establishing project management processes, and supporting FDA submissions while ensuring accountability across various teams.

FitnessHealth CareHospitalInformation TechnologyMedical DeviceSoftware

Responsibilities

Lead cross-functional teams through all phases of product development, from concept through commercialization, in a fast-paced, resource-constrained environment

Develop and maintain detailed project schedules, milestones, and resource plans; drive day-to-day execution through effective meeting cadence, action tracking, and follow-through

Drive clarity around scope, priorities, and ownership, and enable a clear decision-making process; proactively escalate issues with options and recommendations

Track and communicate project budget, BOM cost considerations, and resource allocation in partnership with functional owners

Facilitate design control activities aligned to FDA 21 CFR 820 and ISO 13485, including design inputs/outputs, design reviews, and DHF readiness in collaboration with Quality/Regulatory

Partner with engineering and quality teams to plan and coordinate verification and validation (V&V) activities and ensure milestone readiness

Support risk management activities consistent with ISO 14971, ensuring risks, mitigations, and decisions are tracked and reviewed with appropriate stakeholders

Support planning and execution activities for FDA submissions and related documentation readiness

Design, implement, and continuously improve the company’s project management framework, including phase-gate or milestone models aligned to design controls; standardized plans and reporting; and risk/dependency/change-management practices

Maintain core program artifacts (integrated plan, RAID log, dependency tracker, decision log, change log) and drive consistent, concise status reporting

Identify gaps in process, communication, or tooling and implement improvements that increase predictability and accountability

Act as a unifying force across R&D/Engineering, Quality, Regulatory, Clinical, Marketing/Product, Manufacturing/Operations, and other stakeholders

Influence without authority by building trust and accountability in a matrixed environment

Ensure effective communication across all levels of the organization, including clear written updates and leadership-ready summaries

Drive project documentation quality (accuracy, completeness, consistency) in alignment with the company’s quality management system (QMS)

Support document routing and approvals using document control systems

Support process improvements related to project management, design control, and change control

Qualification

Engineering Project ManagementMedical Device ExperienceDesign ControlsFDA SubmissionsPMP CertificationAnalytical SkillsContinuous ImprovementCross-Functional LeadershipCommunication SkillsProblem-Solving Skills

Required

5+ years of experience in engineering project/program management or a related cross-functional leadership role in the Medical Devices sector

Working knowledge of Design Controls (21 CFR Part 820 / ISO 13485) and experience contributing to or maintaining Design History File (DHF) documentation

Experience driving schedules, dependencies, and risks across cross-functional teams; Strong bias toward action, ownership, and continuous improvement

Excellent verbal and written communication skills; strong conceptual, analytical, and problem-solving abilities

BS (MS preferred) in Engineering or a related field

Ability to operate a motor vehicle and maintain a valid Driver's license

Preferred

PMP certification and/or MBA a plus

Experience in a startup, early-stage, or high-growth environment

Familiarity with regulated product development practices, including verification/validation planning, risk management, and change control

Experience working with PLM/document control workflows

Company

Willow Laboratories

Willow Laboratories, a health and wellness innovator based in Irvine, California who holds 127 issued patents, 48 pending patents, and technologies that are used by leading hospitals around the world.

Founded in 1998

Irvine, California, USA

51-200 employees