1+ months

Instrumentation Systems Engineer

Roche
Santa Clara, CA

POSITION SUMMARY:

Applies intensive and diversified knowledge of design principles, practices and implementation in complex systems and assignments. General responsibilities include design concept generation, participating in design reviews, development and testing to assess performance against design specification; reliability testing, and assessment of system interactions. Makes independent decisions. Assist in the development of manufacturing processes and troubleshooting issues to determine root cause and possible engineering solutions.

ESSENTIAL FUNCTIONS:

  • Consistently uses company concepts, policies and procedures, familiar with and follows standard practices.
  • Projects are assigned with defined scope and goals.
  • Direction is provided by more senior engineering staff, management or project leader.
  • Participates in efforts to define new components, products or processes and identify technical challenges.
  • Makes suggestions to improve work processes.
  • Creates potentially patentable components for systems, or processes.
  • Plans and executes assigned projects; utilizes thorough technical and theoretical understanding of numerous techniques.
  • Analyzes data, evaluates results, forms conclusions and provides/implements process or document improvements.
  • Applies advanced engineering knowledge to projects.
  • Executes experiments; participates in experimental design.
  • Utilizes DOE where appropriate.
  • Participates in technical team activities.
  • Shares knowledge and expertise with others.
  • Participates in project planning, process updates and contributes to experimental design.
  • Prepares and delivers presentations of project results to own or other groups.
  • Monitors work to ensure quality, and continuously promote Quality First Time.
  • Engineering projects to include modification and evaluation of new or enhanced hardware products or systems. Projects may involve assessment of products and/or process problems and selection of new concepts and approaches, origination or modification of material, component and process specifications and requirements.
  • Contribute to the design and development of opto-electromechanical systems, and generating specifications, requirements, test methods and protocols
  • Perform hands-on laboratory tasks in engineering and instrument labs
  • Author and generate systems requirements including lower level technical HW/control requirements, and higher level product and user requirements
  • Execute required testing for technical feasibility, D&D, verification and validation, and reliability testing.
  • Work independently in a cross-disciplinary environment to plan and execute experiments and problem-solve using specialized test equipment and perform experimental data analysis.
  • Perform failure analysis investigations on products, processes, and components.
  • Create detailed drawings, assembly drawings and incorporate redline drawings using SolidWorks
  • Write/modify assembly documentation using Word or PowerPoint and support documentation updates
  • Create design change order (documents, parts or process), and released documentation in Agile.
  • Drive the change order of parts, documents and BOMs using Agile
  • Perform FMEA reviews within engineering and quality groups, with CM and suppliers.
  • Follow GLP and GMP when executing lab and administrative work
  • Ability to interact and communicate effectively and professionally with a wide variety of people and departments across organizational functions within the company, as well as with customer, suppliers, and other people outside the company

MINIMUM QUALIFICATIONS:

Formal Training/Education:

  • BS degree in Mechanical Engineering or Biomedical Device Engineering or equivalent experience of opto-electro/mechanical hardware
     

Experience:

  • Requires a minimum of 4 years of direct work experience as an engineer, product developer (e.g. System Integration Engineer, System Development Engineer, Product Development Engineer, or related occupation) in an industry laboratory setting, with experience in commercially launched product preferred. 
    OR
  • MS degree in a directly related discipline + 2 years of related experience required

Knowledge, Skills, and Abilities:

  • Demonstrates potential for technical proficiency, engineering creativity, collaboration with others and independent thought.
  • Strong understanding of engineering principles and concepts.
  • Detail oriented, proactive, self-motivated and driven
  • Experience in a Quality Environment
  • Candidate must be able to follow directions and adjust to changing priorities in a fast-paced environment. 
  • The ability to learn quickly and work safely is of most importance
  • Positive attitude and ability to multitask
  • Must have experience with developing and integrating complex instrumentation systems which incorporate optical, mechanical, electrical and firmware/software components.
  • Data driven critical thinker who can work independently with minimal guidance
  • Working knowledge of design of experiments, interpretation of test results, failure investigation and excellent problem solving skills
  • Strong verbal and written skills, and be able to write documentation and reports in a structured format
  • Experience in generating system requirements
  • Proficient in and hands-on use of Solidworks or other CAD program
  • Previous medical device or biotechnology industry experience with GMP and GLP experience
  • Design and Development experience
  • Verification and Validation experience
  • Reliability test protocol generation and testing experience
  • Knowledge of analog and digital electronics, hardware test method development, optomechanical design and assembly, electromechanical assembly.
  • Reliable, organized and punctual
  • Able to work independently

Preferred Skills:

  • Programming experience in C/C++, Python, or other
  • Proficient in the use of SolidWorks PDM/EPDM (Product Data Management)
  • Understanding of tolerancing with respect to precision vs non-precision parts, as well as how it relates to the manufacturability of parts
Posted: 2018-10-05 Expires: 2018-12-20

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Instrumentation Systems Engineer

Roche
Santa Clara, CA

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