Medical Device Project Lead: From Concept to Launch

Prismatik; Irvine (CA); On-site; USD 81,000 - 115,000; Full time

Job summary

Prismatik in Irvine, CA is seeking a Project Manager to lead the development of new medical devices from concept through launch. This hands-on role sits at the center of engineering, R&D, quality, and manufacturing to drive Design Control, timelines, and resources.

You will manage risks, ensure regulatory compliance, and mentor teams from early development through final testing, delivering products with the quality and rigor required for medical devices in a fast-paced environment.

Qualifications

• Bachelor's degree in engineering or scientific field.
• Minimum five years of R&D experience in high value roles.
• Minimum three years of project management in medical devices.
• Knowledge of ISO and FDA standards for medical devices.
• PM certification is a plus.

Responsibilities

• Leads the project team through all phases of Design Control to meet scope, time, and quality.
• Creates or directs preparation of documents for Design History Files.
• Determines and tracks resources including time, capital, labor, and equipment.
• Assists management in preparing project proposals covering scope, schedule, and budget.
• Manages progress to align with business strategy and Prismatik’s quality standards.
• Manages timelines, milestones, and resource allocations.
• Identifies risks and bottlenecks; develops mitigation actions.
• Evaluates testing results and provides manufacturing guidance.
• Communicates with stakeholders and vendors to achieve design intent.
• Reports progress and strategy updates to management.
• Produces project reports for management and team members.

Skills

Project management

Design Control

Risk management

Regulatory standards

Education

Bachelor’s degree in Engineering or scientific related discipline

Job description

Prismatik in Irvine, CA is seeking a Project Manager to lead the development of new medical devices from concept through launch. This hands-on role sits at the center of engineering, R&D, quality, and manufacturing to drive Design Control, timelines, and resources.

You will manage risks, ensure regulatory compliance, and mentor teams from early development through final testing, delivering products with the quality and rigor required for medical devices in a fast-paced environment.