What are the responsibilities and job description for the Senior R&D Project Engineer position at Katalyst CRO?
Job Summary
- We are seeking a highly motivated Senior R&D Project Engineer to lead Cost Improvement Projects (CIP), design changes, supplier change initiatives, and product lifecycle management activities within a regulated medical device environment.
- The ideal candidate will possess strong project management skills, medical device product development experience, regulatory knowledge, and the ability to collaborate effectively with cross-functional teams and external suppliers.
- This role will drive engineering projects from concept through implementation while ensuring compliance with quality and regulatory requirements.
- Lead Cost Improvement Projects (CIP) by coordinating activities across internal teams, suppliers, and stakeholders.
- Develop project budgets by evaluating supplier quotations, feasibility studies, capital investments, validation activities, DVT samples, and bioburden requirements.
- Create and manage project plans, schedules, timelines, and deliverables using Microsoft Project.
- Lead design change, supplier change, and alternative sourcing projects to achieve cost savings and business objectives.
- Perform engineering testing, protocol development, test execution, and preparation of technical reports.
- Conduct design reviews and collaborate with R&D, Quality, Regulatory Affairs, Manufacturing, and Supply Chain teams.
- Develop and execute verification and validation activities in accordance with regulatory requirements.
- Support process validation, risk assessments, and product change control activities.
- Review and finalize validation documentation, risk management files, and regulatory documentation.
- Manage engineering change requests and supplier change requests through completion.
- Provide project updates, presentations, and recommendations to senior management.
- Ensure compliance with company quality systems, FDA regulations, and international medical device standards.
- Drive project execution while managing scope, risks, timelines, and budgets.
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related discipline.
- Minimum 6 years of experience in Medical Device Product Development, R&D Engineering, Sustaining Engineering, or Project Engineering.
- Experience leading engineering projects in regulated medical device environments.
- Strong understanding of FDA regulations and medical device quality systems.
- Experience managing supplier change, design change, and cost improvement projects.
- Experience creating project plans and schedules using Microsoft Project.
- Strong communication, leadership, and stakeholder management skills.
- Ability to work independently and manage multiple projects simultaneously.