Product Development Engineer-Integrated Systems

Company: Gilero
Location: Morrisville
Posted on: August 4, 2022

Job Description:

Job Purpose:Responsible for developing new medical devices
Duties: --- Support the development of new products, primarily class I and class II medical devices consisting of mechanical and electro-mechanical systems --- Support the development of system architecture schematics for complex medical devices --- Support product and customer requirement definition and development --- Participate in product and process risk assessments and design reviews --- Write protocols and reports to evaluate product performance --- Develop and evaluate new test methods --- Perform testing and inspection of prototypes and pre-production products --- Assemble and prepare prototypes for testing and client meeting purposes --- Assist with process development activities, write work instructions, and develop in process inspection procedures --- Generate CAD models for test or assembly fixtures --- Write and execute protocols for process, equipment, and design validations --- Investigate and evaluate electrical technologies, system methods, product materials --- Prepare detailed component and assembly drawings --- Prepare documentation to support design history files and regulatory submissions --- Maintain DHF and ensure documents are complete, accurate, and current --- Communicate effectively with customers and vendors in a technical capacity
Skills/Qualifications: --- BS in Engineering or equivalent technical degree --- 0 - 6 years experience in product development, preferred --- Experience with electro-mechanical systems, preferred --- Experience with SolidWorks, Pro/Engineer and/or other 3D CAD modeling software --- Experience with plastics and/or silicones, particularly injection molding, preferred --- Knowledge of medical device regulations (FDA/ISO), preferred
Personal Attributes: --- Meets Gilero Core Values: o Open Communication o Accountability o Customer Focus o Innovation o Efficiency o Excellence o Integrity --- Comfortable and productive in a fast-paced, entrepreneurial environment --- A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high quality service to internal and to external clients --- Commitment to excellence and quality service to external and internal customers --- Commitment to established policies and procedures, while contributing to continuous improvements --- Excellent communication skills (oral and written) --- Proficient (or better) computer skills, including Excel and Word

Keywords: Gilero, Cary , Product Development Engineer-Integrated Systems, Other , Morrisville, North Carolina