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Staff Engineer

Orange County Metro Area, CA

Posted: 12/18/2018 Job Type: Engineering Job Number: JN -122018-23265
Staff Engineer
Lifesciences Industry
Irvine, CA
Duties:Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
  • Must have a Mechanical Engineering Degree, and be proficient in Solidworks. Self-Driven, Hands-on Mechanical, Protocol/Report writing experience, Minitab Statistical Analysis a plus.
Skills: Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations and develop reports
Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion
Lead in the identification and ensure the optimization of complex Manufacturing 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 more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
Develop 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
Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.
Train, coach, and guide lower level employees on more complex procedures
Other incidental duties
Education:Education and Experience:

Bachelor's Degree or equivalent 6 years experience including either industry or industry/education Required Or Master's Degree or equivalent 5 years experience including either industry or industry/education Required Or Ph.D. or equivalent in in Engineering or Scientific field , 2 years experience including either industry or industry/education

Additional Skills:

Proven expertise in usage of MS Office Suite
Ability to read and interpret drawings
Proven expertise in statistical techniques
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
Ability to translate technical information to all levels of the organizations
Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
Knowledge of Six Sigma concepts with ability to apply to work product
Knowledge of Quality Engineering concepts with ability to apply to work product
Advanced problem-solving, organizational, analytical and critical thinking skills
Extensive understanding of processes and equipment used in assigned work
Strong leadership skills and ability to influence change
Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Work is performed independently while exercising considerable latitude in making significant decisions
Set policies and standards that are followed by others
Guides others in resolving basic issues in specialized area based on existing solutions and procedures
Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts
Represents organization in providing solutions to difficult technical issues associated with specific projects
Develops technical solutions to complex problems which require the regular use of creativity
Uses best practices and knowledge of internal or external business issues to improve products/services or processes
Typically resolves complex problems or problems where precedent may not exist
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