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Engineer II (Manufacturing)

Date Posted: 8/19/2020

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Job Description

A large, global medical device company in Irvine has an opportunity for an Engineer ll, Molding and Tooking.  Will Apply knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes. Job Functions- Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills- Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports- Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)- Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes- Establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)- Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work- Other incidental duties assigned by Leadership Level of Independence- Works independently without close supervision- Compares and evaluates possible courses of action after considering various possibilities- Applies his or her knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met- Considers the cause and effect of activities- Determines or effectively recommends course of action after considering potential risks of alternatives- May provide guidance to lower level personnel- Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment- Direction tends to be high level and focused on end results with means of accomplishment left to incumbent
·        Medical manufacturing experience required (manufacturing engineer - working with line layout, supplier management, fixtures/molding/engineer drawings, office suite, technical writing report)

·        Supplier quality background preferred

·        Auditing background preferred

·        Knowledge of molding and tooling preferred

·        Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)

·        Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

·        Basic understanding of statistical techniques

·        Previous experience working with lab/industrial equipment required (if applicable)

·        Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering

·        Solid problem-solving, organizational, analytical and critical thinking skills

·        Solid understanding of processes and equipment used in assigned work

·        Knowledge of and adherence to company Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

·        Knowledge of applicable FDA regulations for medical device industry

·        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 the ability to manage vendors and project stakeholders

·        Ability to build productive internal/external working relationshipsAdhere to all co
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Job Snapshot

  • Employee Type:Full-Time
  • Location:Irvine, CA
  • Job Type:Engineering
  • Experience:Not Specified
  • Education:Not Specified
  • Date Posted:8/19/2020
  • Contact: Teresa LeBeau (949) 265-6070
  • Pay Range: $0.00 - $0.00 Annually
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Job Reference: JO-2007-94917