Project Manager - Manufacturing (ISO 13485)

• Leads projects through New Product Introduction (NPI) process to support product development lifecycle from ideation to commercialization, including regulatory clearance, design transfer, manufacturing scale-up, and inventory build for launch.
• 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.
• Oversees and maintains compliance with design control requirements throughout all project phases, ensuring proper documentation and adherence to FDA and ISO 13485 standards.
• Facilitates design reviews, risk management activities, and stage-gate deliverables within the NPI process.
• Perform other related duties and projects as business needs require at direction of management. 

Minimum Qualifications:

• 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).