Instrumentation Systems Engineer

Instrumentation Systems Engineer

Santa Clara, CA

Contract

JOB SUMMARY:

The Instrumentation Systems Engineer is responsible for the planning, execution, analysis, and reporting of laboratory experiments, as well as associated design and development tasks including generating systems test protocol and test reports, in support of Instrumentation Engineering projects involving opto-electromechanical systems and software. This role is also responsible for on-going support and sustaining tasks associated with legacy hardware platforms. In this hands-on role, you will interface with all levels of the company and collaborates with engineering, SW, marketing, manufacturing, quality, purchasing, regulatory, service, and contract manufacturer and other interdisciplinary groups to design, refine, and test various instrument components/systems for digital pathology projects. The ideal candidate will have an engineering background with experience working in a regulated, medical device environment whom exhibits the desire and ability to collaborate and excel in teamwork and communication, and be able to work independently with minimum guidance.

ESSENTIAL JOB RESPONSIBILITIES:

• Applies multiple engineering disciplines to plan, organize and conduct technical projects testing within design and development environment.
• Contributes to the design and development of opto-electromechanical systems and software, and generating test methods and protocols.
• Performs hands-on laboratory tasks in engineering and instrument labs.
• Performs image quality check on images for internal and external experiments and processes.
• Facilitates technical problem solving through proposed experimentation and alternate designs/approach.
• Executes required testing for technical feasibility, D&D, verification and validation testing.
• Collaborates cross-functionally with Software, Customer Technical Support, Service, and other functions to deliver system-level instrumentation platforms that meet the needs of the company s product portfolios.
• Work independently in a cross-disciplinary environment to plan and execute experiments and problem-solve using specialized test equipment and perform experimental data analysis.
• Performs failure analysis investigations on products, processes, and components.
• Write/modifies documentation using Word or PowerPoint and support documentation updates.
• Creates design change order (documents, parts or process), and released documentation in Agile or a similar tool.
• Drives the change order of parts, documents and BOMs using Agile.
• Provides engineering technical support when needed.
• Other job functions include performing office administrative tasks, lab organization, equipment and test material acquisition and generating reports and presentations.
• Follows GLP and GMP when executing lab and administrative work.
• Maintains organized and complete documentation of activities, and provide regular updates covering progress, problems and solutions.
• Complies with all Quality requirements in a FDA-regulated environment.
• Independently manage day-to-day project activities.
• 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.
• Debugs products through the use of systematic tests to develop, apply, and maintain quality standards for company products.
• Develops, modifies, and executes test plans, automated scripts and programs for testing.
• Participates in efforts to define new components, products or processes and identify technical challenges.
• Participates in project planning, process updates and contributes to experimental design.
• Analyzes and writes test standards and procedures.
• Maintains documentation of test results to assist in debugging and modification of software.
• Analyzes test results to ensure existing functionality and recommends corrective action.
• Consults with development engineers in resolution of problems.
• Ensures quality computer integration into the overall functions of scientific computation, data acquisition, and processing.
• All other duties as assigned.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES (MINIMAL COMPETENCIES)

• Bachelor s degree in Electrical Engineering, Mechanical Engineering or Biomedical Device Engineering or equivalent experience of opto-electro/mechanical hardware.
• At least 10 years of direct work experience as a Systems Engineer (e.g. System Integration Engineer, System Test Engineer, or related occupation) in an industry laboratory setting, with experience in commercially launched product preferred. Or, equivalent combination of advance degree with practical experience to perform at this level.
• Comfortable operating sophisticated computer and instrumentation equipment/hardware.
• Detail oriented, proactive, self-motivated and driven.
• Experience in a Quality Environment.
• Follows 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.
• Data driven critical thinker who can work independently with minimal guidance.
• Must have strong analytical and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system interoperability problems.
• Strong verbal and written skills, and be able to write documentation and reports in a structured format.
• Experience in generating test cases, test protocols and test report.
• 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.
• Reliable, organized and punctual.
• Able to work independently.