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Project Engineer - Peachtree Corners, United States - ALLESET INC
Description
Job DescriptionJob Description
From our corporate headquarters near Atlanta, Georgia to operations in eight countries (the Dominican Republic, China, Hong Kong, Vietnam, India, the Netherlands, UK, USA), GRI-Alleset is a privately held company which focuses on the design, development and manufacturing of disposable medical supplies.
We pride ourselves on developing strong customer relationships, driving new product innovation while adapting to ever changing global market demands.
To learn more about our company, visit us atGRI-Alleset has a career-building opportunity for a Project Engineer to join a dynamic and rapidly growing company. The ideal candidate will be positive, proactive, innovative, and have a "can-do" attitude.
As a Project Engineer, you will play a critical role in leading and coordinating various aspects of product development projects.
You will be responsible for managing the engineering aspects of projects from conception to completion, ensuring adherence to quality standards, regulatory requirements, and project timelines.
Key ResponsibilitiesProject Planning and Execution
Develop project plans outlining scope, objectives, deliverables, timelines, and resources required.
Coordinate with cross-functional teams including R&D, manufacturing, quality assurance, regulatory affairs, and external vendors to ensure alignment and efficient project execution.
Monitor project progress, identify potential risks or roadblocks, and implement mitigation strategies to keep projects on track.Product Design and Development
Lead the design and development of medical devices from concept to commercialization, ensuring compliance with relevant standards and regulations (e.g., FDA, ISO).
Conduct feasibility studies, design reviews, and risk assessments to identify and address technical challenges or opportunities for improvement.Utilize CAD software and other engineering tools to create detailed design specifications, prototypes, and test plans.
Regulatory Compliance:
Work closely with the regulatory affairs team to ensure that all engineering activities comply with applicable regulations and standards.
Support the preparation of technical documentation required for regulatory submissions (e.g., 510(k), CE Mark), including design history files, risk management reports, and test protocols.
Develop and execute test plans to validate product performance, reliability, and safety throughout the development lifecycle.Collaborate with quality assurance teams to establish and maintain quality management systems, including design controls, CAPA (Corrective and Preventive Actions), and change management processes.
Project Documentation and Reporting:
Maintain accurate and up-to-date design file documentation.
Communicate project status, milestones, and issues to stakeholders through regular meetings, presentations, and written updates.
Qualifications
Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field). Master's degree preferred.
1-2 years of experience in medical device product development or a related industry is a plus.
Proficiency in CAD software (e.g., SolidWorks, Autodesk Inventor) and other engineering tools(i.e. Minitab).
Strong understanding of relevant regulations and standards (e.g., FDA QSR, ISO 13485, IEC a plus.
Familiar with Plastic related extrusion processing is a plus (i.e. film extrusion, injection molding, blow molding, tubing extrusion).
Familiar with one of the sterilization Method (Ethylene Oxide, Gamma, E-beam, Autoclave) is a plus.
Excellent project management skills, including the ability to prioritize tasks, manage resources, and adapt to changing priorities.
Effective communication and interpersonal skills, with the ability to collaborate across functions and influence decision-making.
Fluent in Mandarin is a plus.
Travel
15% of
international/Domestic
travel is requested for this position
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