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Sr. Engineer
Ref No.: 18-14347
Location: Irvine, California
Key Responsibilities
 
• Implement design control and product development activity to bring new or refined products to market.
 • Develop test and inspection tools and methods.  Validate test methods.
• Develop supplier qualification test and inspection tools. Lead communication and tracking with supplier for validation activities.
• Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.  Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Develop, update, and maintain technical content of risk management files
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Train, coach, and guide lower level employees on routine procedures


Knowledge
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering and design control.
• Strong problem-solving, organizational, analytical and critical thinking skills    
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change


Problem Solving / Job Complexity
• Develops solutions to a variety of complex problems
• Identifies opportunities for process improvements​

Discretion / Latitude and Supervision
• Work is performed independently and reviewed upon completion for adequacy in meeting key objectives
• Participates in determining objectives of assignment; plans schedules and arranges own activities in accomplishing objectives
• Acts as a resource for colleagues with less experience​ 



Impact
• Contributes to the completion of significant organizational projects and goals; Input on overall objectives and long-range goals of the organization is given serious consideration
• Failure to conclude their piece of a project would have impact causing schedule delay and/or addition of resources​



Liaison
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations​



Typical Education / Experience
• Bachelor's Degree or equivalent in Engineering or related field with 4 years related industry experience Required or
• Master's Degree or equivalent in Engineering or related field with 3 years related industry or industry/education experience Required or
• Ph.D. or equivalent in Engineering or related field with 0 years’ experience Required
• Other: CQE (Certified Quality Engineer), if applicable  Preferred
• Proven expertise in usage of MS Office Suite; CAD experience preferred
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Working knowledge and understanding of statistical techniques
• Previous experience working with lab/industrial equipment required
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations​