Bachelor's degree in Mechanical, Biomedical, or Manufacturing Engineering.
6+ years of experience in Medical Device Product Development or R&D Engineering.
Proven expertise in leading projects within regulated medical device environments.
Strong understanding of FDA regulations and quality systems.
Experience in managing supplier and design changes, as well as cost improvement initiatives.
Proficient in creating project plans using Microsoft Project.
Excellent communication and leadership skills.
Responsibilities
Lead and coordinate Cost Improvement Projects (CIP) with internal teams and suppliers.
Develop project budgets and evaluate supplier quotations and feasibility studies.
Create and manage project schedules, timelines, and deliverables using Microsoft Project.
Drive design change and alternative sourcing projects to optimize costs.
Conduct engineering testing and prepare technical reports based on results.
Facilitate collaboration with cross-functional teams during design reviews.
Implement verification and validation activities in compliance with regulatory standards.
Benefits
Opportunity to lead impactful projects in a highly regulated medical device environment.
Collaborative work culture engaging cross-functional teams.
Professional development opportunities within the medical device sector.
Hands-on role in driving engineering projects from concept to implementation.
Full Job Description
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.
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.
Education & Experience:
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.
