Project Manager - Medical Device

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

We're looking for a Project Manager to lead the development of new medical devices from concept through launch.

This is a hands-on role at the center of engineering, R&D, quality, and manufacturing, where you'll drive projects through Design Control, manage timelines and resources, and keep teams aligned from early development through final testing. You'll tackle technical and project challenges, manage risk, and make sure products move forward with the quality and rigor required in a regulated environment.

Essential Functions

• Leads the project team through all phases of Design Control to achieve project goals within established scope, time, and quality constraints.
• Creates or directs preparation of all documents including, but not limited to protocols, reports, traceability matrices, SDS documents and labeling required for the Design History Files of medical devices.
• Determines and tracks resources such as time, capital, labor, and equipment required to complete projects.
• May assist executive management in the preparation of project proposals including scope, schedule, budget, and deliverables.
• Manages progress of projects to ensure alignment with business strategy, sound application of engineering principles, and adherence to Prismatik’s Quality Manual and applicable industry standards.
• Manages and implements appropriate action with respect to timelines, milestones, planning, and resource allocations.
• Identifies elements impacting project, such as personnel issues and project gaps, bottlenecks, and risks. Develops solutions and/or implements corrective actions to ease issues, eliminate delays, and mitigate risks using appropriate knowledge, skills, and techniques.
• Evaluates and analyzes final testing results. Provides manufacturing guidance.
• Communicates with project stakeholders, various departments, and applicable vendors to achieve design intent.
• Updates management regarding project strategy, progress, and alignment with executive direction.
• Creates and produces reports regarding projects for management and team members.
• Performs other related duties and projects as business needs require at direction of management.

Minimum Qualifications

• Bachelor’s degree in Engineering or scientific related discipline, preferred.
• Minimum five (5) years of experience in R&D performing higher value-added roles and functions.
• Minimum three (3) years of experience in project management; medical device industry experience, a plus.
• Demonstrated knowledge of International Organization for Standardization (ISO) and Food and Drug Administration (FDA) standards and requirements for medical devices.
• Certification in Project Management, a plus.

Pay range: $81,000-115,000/yr

Exact compensation may vary based on skills and experience.

This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.