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Design Control Engineer
Ref No.: 18-66134
Location: santa Ana, California
Position Type:Full Time/Contract
Start Date: 09/10/2018
 Job Description: 
 
Coordinate design control activities in support of product development and life cycle processes between customer team and offshore team
Demonstrated experience with formal problem-solving methodologies
Good Understanding of ISO 13485 and FDA Quality System Regulations,
Experience in developing design history file
Experience in Medical Device Risk Management Process (ISO 14971)
Experience in application of ergonomics and human factors engineering principles in medical device product development and familiarity with IEC 62366 standard
Experience in Ophthalmic product development is preferred
Develop and or update design traceability matrix (traceability between user need, design input, design output, design verification and design validation)
Responsible for developing/updating quality plan
Prepare, execute, review and approve design verification test protocols and reports
Determine statistically relevant sample sizes
Able to lead risk management activities including creation/update of Risk Management Plan, Hazard Analysis, Design FMEA, Risk Benefit Analysis and Risk Management Final Report
Investigate, identify and implement corrective and or preventive actions to close design control CAPAs
Assess design control procedure updates and determine product and business impact
Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders (ECO), etc.
Work with manufacturing engineer/process engineer to ensure necessary process controls are in place
Work with manufacturing engineer/process engineer during process validation execution and protocol and report review and approval
Assess impact of validations on SOPs, process sheets, FMEAs and Quality Control Plans