Description:
We are seeking an experienced Project Engineer to support medical device and combination product development projects. The ideal candidate will lead Use-Related Risk Analysis (URRA), Systems Engineering, and Design Control activities while collaborating with cross-functional teams to ensure successful product development and regulatory compliance.
Key Responsibilities
- Lead and coordinate Use-Related Risk Analysis (URRA) activities across multiple projects.
- Facilitate cross-functional meetings to develop and maintain risk management documentation.
- Collaborate with Human Factors, Quality, Clinical, Manufacturing, and Engineering teams to identify hazards, risks, and mitigation strategies.
- Develop and maintain Design History Files (DHF) and Design Control documentation.
- Support Systems Engineering activities, including requirements management, traceability, system architecture, and risk assessments.
- Perform and review Use-Related Risk Assessments, Design FMEAs, and Process FMEAs.
- Monitor project schedules, milestones, risks, and deliverables while communicating project status to stakeholders.
- Support change management, third-party vendor coordination, and Quality by Design (QbD) activities.
- Ensure compliance with FDA regulations, ISO standards, and medical device quality requirements.
Required Qualifications
- BS in Engineering, Science, or a related discipline with 10+ years of experience, or MS with 8+ years of relevant experience.
- 5+ years of experience in pharmaceutical, medical device, combination product, or other regulated industries.
- Expertise in Design History File (DHF) management and Design Control documentation.
- Strong knowledge of Systems Engineering, product development, requirements management, and traceability.
- Experience with Use-Related Risk Analysis (URRA), Human Factors Engineering, Risk Management, Design FMEA, and Process FMEA.
- Familiarity with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR.
- Experience with project scheduling, document management tools, and vendor management.
- Excellent analytical, organizational, communication, and cross-functional collaboration skills.