Corentec Co., Ltd. · 1 day ago
Product Engineer
United States
Full-time
Remote
Mid Level
3+ years expCorentec Co., Ltd. specializes in the design, manufacturing, and marketing of orthopedic implants, focusing on the Hip and Knee Implant markets. They are seeking a Product Engineer to work with surgeons and sales representatives to design, develop, and refine medical devices, managing the full lifecycle from concept to manufacturing while ensuring regulatory compliance.
Health CareManufacturingMedicalMedical Device
Hiring Manager
Brian May
Responsibilities
Work with surgeons and sales representatives to design, develop, and refine patient-specific or surgeon-specific medical devices
Manage the full lifecycle from concept (CAD, prototyping) to manufacturing, ensuring strict regulatory compliance
Qualification
Required
Familiarity with regulatory standards including but not limited to 21 CFR Part 820, ISO 13485 and FDA's guidance document on design control
Proven ability to lead projects from concept through commercialization
Strong problem-solving skills and ability to collaborate with cross-functional teams including R&D, manufacturing, quality, regulatory, marketing, and sales
Excellent communication skills for translating clinical needs into technical specifications
Parametric CAD modeling proficiency, SolidWorks preferred
Bachelor's degree in mechanical engineering, biomedical engineering, or related engineering discipline
Minimum 3 years of experience in orthopedic product development
Preferred
SolidWorks preferred
Company
Corentec Co., Ltd.
Corentec designs, manufactures, and markets a full line of Orthopedic Implants focusing on the Hip, Knee and Spine Implant markets.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2016-11-01Series Unknown
2004-01-01Series Unknown
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