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Design control engineer
Ref No.: 18-69064
Location: Santa Ana, California
Position Type:Full Time/Contract
Start Date: 09/19/2018
 
Relevant Experience
(in Yrs)
4+
Technical/Functional Skills
  • Coordinate design controlactivities 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 13485andFDA Quality System Regulations,
  • Experience in developing design history file
  • Experience inMedical 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 (5years) 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 goodtime 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)