Previous Job
Previous
Manufacturing Engineer
Ref No.: 18-39834
Location: Northridge, California
Start Date / End Date: 07/30/2018 to 01/30/2019
Company: Artech Information Systems
Job Title: Manufacturing Engineer
Location: Northridge, CA
Duration: 6+ months
Job ID: 18-39834
 
POSITION DESCRIPTION:
The individual chosen for this position will primarily be responsible for executing tasks in support of next generation sensor manufacturing advancements, validations, and  launches. These responsibilities include but are not limited to substrate development, chemistry application/development, writing technical plans and reports, planning and executing experimental protocols, and interpreting and analyzing in-vitro and in-vivo data, and executing process validation deliverables. Lastly, this individual will work closely with Quality, Regulatory, R&D, and Management to ensure critical business needs and timelines are met.
 
The qualified candidate will make detailed observations, analyze data, interpret results, and develop strategies for implementing solutions. This candidate will work with new processes to aid in manufacturing glucose sensors. Prepare technical reports, summaries, protocols, and quantitative analysis. Maintain familiarity with current scientific literature. Exercise judgment within generally defined practices and policies in selecting methods and techniques for process development, characterization, and validation (IQ/OQ/PQ).
 
POSITION RESPONSIBILITIES:
Responsibilities should show the key accountabilities for the role.
  • Support glucose sensor manufacturing improvements and validations – IQ / OQ / PQ
  • Drive process development for new sensor platforms and execute chemistry characterization and process validation
  • Interface with R&D, quality, and regulatory to align deliverables with business needs and expectations in a timely manner
  • Execute engineering protocols to understand sensor performance through in-vitro test systems
  • Use statistical methods to analyze data obtained from planned protocols
  • Learn and understand principles of sensor performance to drive process improvements
  • Perform other related duties as assigned
 
BASIC QUALIFICATIONS:
The Basic Qualifications must accurately reflect experience required. Basic Qualifications must be evident on the resume. They must be objective and not subjective, (examples of subjective include excellent communication skills, strong leadership skills, etc.). Basic Qualifications must be relevant to the job.   For example, a Basic Qualification stating “high school degree or GED” is objective. A Basic Qualification stating “high school or equivalent” would not be objective.
 
REQUIRED EDUCATION: 
Bachelors in Engineering
REQUIRED YEARS OF EXPERIENCE:  Use targeted minimums instead of ranges.  Example:  2+ years instead of 2-4 yrs.
Bachelors in Engineering + 1+ years professional experience OR
Advanced Degree + 1 year professional experience
 
REQUIRED KNOWLEDGE:
  • Experience in analyzing data sets and performing relevant statistical analysis
  • Experience with MS Office suite, particularly in Word & Excel
  • Experience writing technical reports, procedures, and/or reference documents
  • Process development and/or improvement experience
  • Experience with MiniTab statistical analysis software and/or equivalent
  • Familiar with practices such as IQ, OQ, PQ, product development, and process characterization
 
DESIRED/PREFERRED QUALIFICATIONS
  • Medical device or healthcare industry experience
  • Cleanroom experience on a manufacturing line
  • Ability to multitask and meet deadlines
  • Excellent verbal and written communication skills
  • Motivated problem-solver with an understanding of validation limitations and regulatory requirements/restrictions
  • Comfortable working around various chemicals, buffers, and machines in a fast-paced environment
  • Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations
 
PHYSICAL JOB REQUIREMENTS: Physical capabilities to perform the job
  • The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this job, the employee is regularly required to be independently mobile.  The employee is also required to interact with a computer, and communicate with peers and co-workers.
  • Ability to travel up to 10% of the time.
  • Extended periods of time doing computer-based work.
 
Thanks
Rajiv Maruthi
Rajiv.maruthi@artech.com