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Staff Engineer

Date Posted: 9/13/2019

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Job Description

A global medical device company in Irvine, CA is looking for a Staff Engineer to assist the R&D team in reviewing and updating documentation and standards for the company's products according to New Medical Device Regulations (MDR).

Job Duties:

  • Lead in the identification and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards
  • Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) on a simple product line(s) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
  • Train, coach, and guide lower level employees on more complex procedures
  • Oversee manufacturing support tasks; give instruction to engineers/ technicians on conducting tests; train engineers/ technicians and provide feedback; and coordinate engineer/ technician work
  • Lead and establish complex project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
  • Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations, black belt thought map)
  • Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
Skills & Qualifications:
  • Bachelor's Degree or equivalent with 6+ years' experience or Master's Degree and 5+ years' experience in medical device or pharma required
  • 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 company 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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Job Snapshot

  • Employee Type:Full-Time
  • Location:Irvine, CA
  • Job Type:Biotech, Engineering
  • Experience:Not Specified
  • Education:Not Specified
  • Date Posted:9/13/2019
  • Contact: Sun Sa (949) 265-6070
  • Pay Range: $55.00 - $60.00 Hourly
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Job Reference: JO-1909-70247