Product Development Engineer

Company: Gilero
Location: Pittsboro
Posted on: August 8, 2022

Job Description:

Job Purpose:Responsible for developing new medical devicesDuties:--- Support the development of new products, primarily class I and class II single-use medical devices--- Lead Project Management activities such as budgets, resources, timelines, and deliverables--- 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 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 capacitySkills/Qualifications:--- BS in Engineering or equivalent technical degree--- 0 - 6 years experience in product development, 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), preferredPersonal Attributes:--- Meets Gilero Core Values:o Open Communicationo Accountabilityo Customer Focuso Innovationo Efficiencyo Excellenceo 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 Wor

Keywords: Gilero, Durham , Product Development Engineer, Engineering , Pittsboro, North Carolina