Project Manager - Manufacturing

Prismatik • Irvine, CA

103d • $95,600 - $125,000

About The Position

The position involves leading projects through the New Product Introduction (NPI) process to support the product development lifecycle from ideation to commercialization. This includes regulatory clearance, design transfer, manufacturing scale-up, and inventory build for launch. The role requires managing Class II medical device projects from early concept to launch, ensuring compliance with design control requirements throughout all project phases, and maintaining adherence to FDA and ISO 13485 standards.

Requirements

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related engineering field.
• Minimum five (5) years of project management experience in Class II medical device manufacturing or similarly regulated industries.
• Strong working knowledge of design control principles (21 CFR 820.30, ISO 13485) and NPI processes.
• Experience supporting stage-gate business cases, including project approval pitches with schedules, resource needs, and COGS estimates.
• Demonstrated success leading cross-functional teams through product development and launch.
• Project Management Professional (PMP) or equivalent project management certification required.
• Demonstrated experience with product lifecycle management (PLM).

Responsibilities

• Leads projects through New Product Introduction (NPI) process to support product development lifecycle from ideation to commercialization.
• Leads and manages Class II medical device projects from early concept to launch, including regulatory clearance and inventory build.
• Develops and maintains detailed project plans, schedules, deliverables, risk registers, budget, and resource allocations.
• Monitors project progress to ensure projects are executed on schedule and within approved financial targets.
• Proactively identifies issues and implements mitigation strategies to minimize risks.
• Partners with project cross-functional stakeholders to align project deliverables and ensure on-time, on-budget execution.
• Prepares and delivers regular project updates, dashboards, and presentations.
• Serves as the primary communication liaison between project stakeholders and maintains comprehensive project documentation.
• Partners with project stakeholders to prepare and present stage-gate project approval pitches, including detailed timelines, resource planning, and cost of goods sold (COGS) estimates.
• Drives New Product Introduction (NPI) activities, ensuring readiness across design, manufacturing, supply chain, and quality functions.
• Facilitates design reviews, risk management activities, and stage-gate deliverables within the NPI process.
• Performs other related duties and projects as business needs require at direction of management.

What This Job Offers

• Job Type: Full-time
• Education Level: Bachelor's degree