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, or Project Engineering.
Experience leading engineering projects in regulated environments.
Strong understanding of FDA regulations and medical device quality systems.
Experience managing cost improvement, supplier change, and design change projects.
Proficient in using Microsoft Project for project planning and scheduling.
Strong communication, leadership, and stakeholder management skills.
Responsibilities
Lead Cost Improvement Projects (CIP) by coordinating with internal teams, suppliers, and stakeholders.
Develop project budgets by assessing supplier quotations and feasibility studies.
Create and manage project plans and timelines using Microsoft Project.
Lead design and supplier change projects to achieve cost savings.
Conduct engineering testing and prepare technical reports.
Collaborate with R&D, Quality, and Regulatory Affairs teams during design reviews.
Execute verification and validation activities under regulatory guidelines.
Benefits
Opportunity to lead innovative engineering projects in the medical device field.
Collaborative work environment with cross-functional teams.
Engagement in cost-saving initiatives that have a direct impact on product lifecycle management.
Exposure to regulatory compliance processes in a heavily governed industry.
Full Job Description
Job Description:
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.
Roles & Responsibilities:
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.
Requirements:
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.
bility to work independently and manage multiple projects simultaneously.
