Senior R&D Project Engineer

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.