Engineer II, Systems

POSITION SUMMARY:

The Systems Engineer II will be called upon to work in the areas of requirements and specifications development and management, system integration and test of electromechanical, fluidic, thermal control, and imaging systems, and formal verification and validation testing, under the guidance of senior team members. The incumbent should be able to analyze data, draw conclusions and make recommendations on relevant data and present findings at a greater level of independence on more advanced tasks than junior level engineers.

DUTIES AND RESPONSIBILITIES:

* Work with cross-functional team to support the design and development of MSD Instrumentation
* Experimentally and analytically characterize system and subsystem performance and capabilities
* Design, implement and optimize software sequences for automation of manual assay protocols on MSD instrumentation
* Lead the development and documentation of failure modes, effects and criticality analyses
* Participate in and/or lead the development of system design requirements and specifications
* Develop and execute system design verification and validation test plans
* Develop and implement system and subsystem reliability test plans
* Generate and implement change orders to promote product design and process improvements
* Specific duties may vary depending upon departmental requirements

EXPERIENCE AND QUALIFICATIONS:

* Bachelor's degree in Systems, Mechanical, or Electrical Engineering or a closely related field required
o Master's degree preferred
* Minimum 5 years of industry relevant experience
* Minimum 5 years of experience with use and integration of analytical laboratory instrumentation
* Experience in scientific or medical instrumentation strongly preferred including various manufacturing methods/options and design ROI in a project driven environment
* Experience in and ISO cGMP environment preferred
* Understanding of programming and data analysis tools such a Python, Metlab, Minitab, or similar experience

KNOWLEDGE, SKILLS AND ABILITIES:

* Solid knowledge of the product development process with specific cross-disciplinary systems integration expertise
* Working knowledge of analytical techniques, experimental design and statistical analysis
* Excellent analytical and problem solving skills
o Demonstrated ability to organize and move project tasks forward in an orderly and structured fashion
* Demonstrated ability to meet deadlines, manage processes through to completion and coordinate a high level of activity under a variety of conditions and constraints
* Understanding of ISO and/or FDA cGMP standards and their documentation requirements
* Proficiency in MS Office suite and engineering computing software (e.g. graphics editing, general statistics, etc.)
* Excellent oral, written and interpersonal skills
o Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of project status
o Excellent documentation skills, technical writing and presentation skills
* A wide variety of creativity and latitude is expected including the ability to multi-task in an environment with changing priorities

PHYSICAL DEMANDS:

This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.

WORK ENVIRONMENT:

This position is performed in R&D, light-manufacturing, and engineering office environments.