In this position, you will play a crucial role in connecting Product Development with Manufacturing to create high-quality medical devices. Your efforts will aid in launching new products, reducing costs, and developing new manufacturing processes.
Responsibilities:
- Manage engineering aspects of our Quality Management System, including:
- Design Controls
- Risk Analyses (DFMEA)
- Design History Files (DHF)
- Device Master Records (DMR)
- Engineering Change Notices
- Develop product extensions, modifications, upgrades, rework, and end-of-life plans.
- Ensure compliance of existing products with company and industry standards.
- Conduct design verification and validation activities, including testing protocols, data collection, analysis, and report preparation.
- Oversee the transition to manufacturing, including vendor coordination.
- Assist Clinical and Regulatory Affairs with FDA submissions and inquiries.
- Complete additional tasks as assigned by management.
Qualifications:
- Bachelor's degree in Mechanical Engineering required; Master's preferred.
- At least 3 years of experience in engineering or a related field, preferably in medical devices or orthopedics.
- Proven experience in supporting production products, implementing cost-saving measures, and enhancing processes.
- Strong understanding of machining processes, including CNC machining, additive manufacturing, and metal/plastic finishing.
