What are the responsibilities and job description for the Project Engineer II position at ALLESET INC?
Who are we?
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 at www.gri-alleset.com.
Key Responsibilities
Project 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.
- 5 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 60601).is 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. With other duties as assigned.
Travel
15% of international/Domestic travel is requested for this position
Work Environment:
- Our work environment is casual and fun, but we also work hard.
Teammate Benefits:
- Medical, supplemental gap, dental, vision insurance and 401(k)
- Development opportunities to grow your career with a global company
EOE/M/F/D/V