Staff Engineering, Manufacturing Engineering

Location
Pleasanton, CA
Salary
Competitive
Posted
March 20 2017
Ref
45766BR
Position Type
Full Time
Job Description

Essential Functions

  • Develop, implement, and qualify robust, high quality, and cost effective processes for manufacturing new and/or existing world class products in an ISO 13485 environment.
  • Provide technical leadership on cross functional teams for high throughput oligonucleotide operations, business development and planning, and R&D activities.
  • Lead equipment/process/facility specification & validation activities, process optimization, technology transfer, and new product scale-up.
  • Lead technology transfers from R&D to Manufacturing and/or from manufacturing

site to manufacturing site.

  • This position will have responsibilities for the evaluating existing processes and facility layouts and assist in generating the future strategy to maximize operating efficiency, sustainability, and growth.
  • Perform project management functions.
  • Successfully troubleshoot equipment and process problems in Manufacturing.
  • Perform design and process risk assessments, such as FMEA.
  • Design and conduct engineering experiments, critically analyze complex data using knowledge of advanced engineering statistics, and communicate results in a team environment.
  • Identifies and solves engineering problems
  • Exercise knowledge of Lean/Six Sigma principles in manufacturing.
  • Conduct process analysis and root cause analysis for manufacturing processes. Utilizes PPI / DMAIC tools to promote a disciplined investigation approach.
  • Investigates, creates and develops new methods and protocols for project advancement.
  • Develop manufacturing documentation such as engineering changes, BOMs, fab drawings, flow diagrams, SOPs, Procedures, and assembly drawings. Develop and maintain records on equipment manufacturers' technical notices, upgrades and safety issues.
  • Maintains accurate records & training file in accordance with relevant Thermo Fisher Scientific required standards to support patent application and defense as well as other international standards (e.g. ISO compliance, GLP/GMP requirements, etc.).
  • Develop and deliver operator and maintenance training and certification.
  • Monitor and collect data regarding systems performance and report to management; utilize statistical process controls. Identify existing and potential problems and develop resolutions. Proactively identify problems before they occur, recommend solutions and implement changes to design and/or process as necessary.
  • Initiates, directs and executes engineering research and/or development strategies through engineering staff or individual studies.
  • Proactively identify future projects, specifications, and benefits.

Qualifications:

  • Requires a bachelor's degree or higher in Chemical Engineering or related discipline. Requires a minimum of eight years of relevant experience in successfully performing process engineering activities.

Skills/Requirements:

  • Must have manufacturing experience, with strong understanding of ISO 13485 and cGMP quality requirements.
  • Excellent project management and interpersonal skills are required, providing the ability to inspire, motivate, and collaborate with others.
  • Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing projects and priorities.
  • Experience in computer-aided design and analysis tools including SolidWorks, JMP, MiniTab, Word and Excel/ VBA
  • Familiarity with design for six-sigma (DFSS) and critical parameter management (CPM) processes is desirable.
  • Knowledge of life-science research market a plus; instruments, protocols, molecular biology, and biochemistry.
  • Excellent verbal and written communication skills and the ability to interpret and summarize scientific results in a clear, concise, accurate manner.
  • Demonstrated expertise in engineering techniques/fundamentals and analytical problem solving skills.
  • Proven ability to lead and provide work direction required.
  • Proficient in product and process change controls and risk management
  • Broad experience in fabrication techniques such as molding, castings, machining, forming, bending, etc. is a plus
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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.