Product Development Engineer-Integrated Systems
Company: Gilero
Location: Morrisville
Posted on: August 4, 2022
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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
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