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Design control engineer
Ref No.: 18-66150
Location: santa Ana, California
Position Type:Full Time/Contract
Start Date: 09/10/2018
  
Technical/Functional Skills        
• 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
 
Experience Required
• Project management experience is required
• Minimum (3 years) of Quality experience in medical device industry
• ASQ Certification as a Quality Engineer is preferred
 
Roles & Responsibilities
• 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
 
Generic Managerial Skills
• Must have strong organizational, analytical and problem-solving skills
• Must have good time management skills
• Ability to work in a team proactively, flexibly in an environment
 
Education
• BS or MS degree (Mechanical, Biomedical Engineering, or related technical field)