Design Assurance Quality Eng Tech II

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

Job Summary:

The Design Assurance Quality Engineering Technician II position is responsible for the preparation and testing of pre-production devices to support the product development process in the execution of Test Method Validation (TMV).  This individual will work closely with Quality Engineers and Product Development Engineers to understand and challenge proposed Test Methods developed to verify product specifications through testing. 

Job Details:

1. Associate is responsible to follow requirements of TMC Quality System; including but not limited to document/data control, compliance with procedures, and change control practices.
2. Read and follow written instructions, engineering drawings, and related documentation.
3. Understands metrology and inspection techniques.  Focus on performing basic product testing on prototype, pre-production, and/ or final design products.  Testing performed typically includes use of equipment such as: measuring dimensions using pin gauges, laser micrometers, rulers, length gages, protractors, measuring microscopes, Instron testing, bench testing using small or large fixtures or jigs, visual inspection.  Has experience in performing inspections on Vision Systems and CMMs.
4. Tabulate experimental data utilizing statistical programs.
5.  Assists in compiling technical reports and summaries.
6. Ability to advise on TMV approach and perform test method validation testing as defined by a protocol.
7. Maintain a lab notebook

Support other lab and Design Assurance department operations tasks as needed

Position Requirements:

• Knowledge, Skills and Abilities
  • Requires a logical thought process and decision-making ability to make product acceptability choices based upon quality criteria, engineering criteria, testing results and product requirements. 
  • Effective communication and organizational skills.
  • Advanced computer skills (i.e., Microsoft Word and Excel),
  • Strong ability in running data analysis in statistical packages (i.e., Minitab, JMP, Statistica)
  • Demonstrated ability to keep neat, accurate, and complete records and data collection.
  • Advanced Mathematical knowledge and aptitude, including but not limited to data analysis, capability, hypothesis testing, and GRR.
  • Ability to use testing equipment (i.e., calipers, micrometers, microscope, optical comparator, Instron, Friction Tester, Laser Mic, etc.), vision equipment, CMMs.
  • Must have 20/20, equivalent, or corrected vision.
  • Attention to detail and the ability to solve basic problems and recommend solutions. 
  • Ability to notice trends and differences in raw data.

• Background Experience
  • Associates degree in engineering; scientific discipline or equivalent work experience  
  • Certified Quality Inspector preferred
  • Prior technical engineering, Quality Control, or manufacturing support experience is preferred.
  • Three (3) years’ experience in inspection and testing in medical, automotive, or contract manufacturing industry.  Preferably in an ISO 9001, ISO 13485, and/or FDA regulated environment.
  • Root Cause Analysis Training preferred

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.