Project Engineer

Job Overview

We are seeking a highly organized and detail-oriented Project Engineer to support the development of catheter-based medical devices.

This role combines engineering knowledge with basic project management tasks, ensuring all technical documentation, testing, and regulatory compliance activities are completed on time and meet industry standards.

The ideal candidate will have relevant experience in the medical device industry, with a strong understanding of FDA and EU regulations, and proficiency in project scheduling and documentation management.

This role involves managing documentation, creating and maintaining project schedules, coordinating cross-functional activities, and ensuring compliance with regulatory requirements.

Key Responsibilities

Project Management :

• Develop, manage, and update detailed project schedules to track milestones, deliverables, and timelines using tools like Microsoft Project or similar software.
• Coordinate and communicate with cross-functional teams (e.g., regulatory, quality, engineering) to ensure project timelines are met.
• Assist Sr, Program Manager in reporting project progress and risks to senior management and other key stakeholders.

Documentation & Compliance :

• Author and update key project documents, including Design History Files (DHFs), requirements documents, protocols, risk assessments, and technical reports.
• Ensure all documentation complies with FDA, ISO 13485, and EU Medical Device Regulations (MDR).
• Maintain and manage Design Inputs and Outputs, Design Verification and Validation protocols (DVP&R), and traceability matrices.

Testing & Reporting :

• Support testing activities by creating test protocols, coordinating test execution, and compiling engineering reports.
• Analyze test data and prepare comprehensive test reports for regulatory submissions.
• Collaborate with quality teams to resolve any issues arising during testing and validation processes.

Regulatory Support :

• Assist in the preparation of technical documentation for FDA 510(k) submissions and EU CE Mark filings.
• Ensure all project activities adhere to regulatory requirements and internal quality system processes.

Qualifications

Education :

Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.

Experience :

• Minimum 3 years of experience in a medical device engineering or project planning role.
• Familiarity with regulatory requirements for medical devices (FDA 21 CFR 820, ISO 13485, EU MDR) and Design Control principles.
• Experience managing and maintaining project schedules and technical documentation in a regulated industry.

Skills & Competencies :

• Software Proficiency : Strong proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Experience using Microsoft Project (or equivalent project management tools) for scheduling and timeline management.
• Familiarity with document management systems (e.g., MasterControl, Grand Avenue Software, etc) for handling design history files and other regulated documentation.
• Excellent written and verbal communication skills, with the ability to write clear and concise technical documents, protocols, and reports.
• Strong organizational skills and attention to detail, with the ability to manage multiple priorities in a fast-paced environment.
• Strong problem-solving abilities and a proactive approach to addressing challenges and meeting deadlines.

Preferred Qualifications :

• Previous experience working with catheter-based medical devices or similar minimally invasive technologies.
• Familiarity with product lifecycle management (PLM) software like Windchill or Agile is a plus.
• Experience in a cross-functional product development environment.

Why Join Us?

• Contribute to the development of life-saving medical devices in a fast-growing company.
• Collaborate with a passionate, multidisciplinary team in a highly regulated environment.
• Competitive salary and benefits package, with opportunities for professional development and growth.

Equal Opportunity Employer : We are committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other protected characteristic.