Product Development Engineer
Company: Gilero
Location: Pittsboro
Posted on: August 8, 2022
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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
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