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Test Engineer

Test Engineer

  • 2021-25272.1
  • Ann Arbor, Michigan, United States

We are seeking an outstanding Test Engineer to join the Advanced Technology Group to support the design and development and testing of novel platform automated digital PCR prototype systems for clinical diagnostics market. In this role, you will primarily be responsible for actively participating in the Product Development/Design Control process of instruments, consumables and reagents.  This position will be based at our Ann Arbor, MI campus.  In addition, this position requires owning the risk management process for new products as well as supporting other aspects of the Quality System. You will also interact with mechanical, electrical, software, manufacturing and firmware engineers to support failure root cause analysis. The candidate should have proven success in understanding complex systems, efficiently designing and executing experiments, performing data analysis and communicating results.

Responsibilities

  • Lead testing activities to ensure appropriate QC testing is implemented.
  • Lead risk management activities for new products and update risk files during the change control process as needed.
  • Work with project team to bring up new tests and draft test protocols.
  • Ensuring trace matrices from requirements to specifications to verification to validation to labeling are complete.
  • Support failure analysis efforts through basic experiment planning, execution, documentation and reporting.
  • Work closely with Systems Engineering, Assay Development and Product Development in all aspects of new product development and transfer to manufacturing.
  • Communicate results effectively, guiding the team through data and your observations on critical design decisions.
  • Assist Design Engineers in creating documentation for manufacturing processes and interfacing directly with manufacturing to ensure success.

Qualifications

Minimum Qualifications:

  • Bachelor’s degree or equivalent in a related engineering discipline.
  • 5+ years’ experience or equivalent combination of education and experience.
  • Ability to accurately and consistently follow detailed procedures.
  • Experience with lab equipment such as microscope, power sources, oscilloscopes and multimeters.

Preferred Qualifications:

  • System level V+V experience across instruments, chemistry and software.
  • Technical background that can be applied to hardware, software and chemical design/development.
  • Experience translating requirements documents into test cases, assigning test methods.
  • Experience mapping test cases to product requirements.
  • Hands-on lab skills including prototyping, testing, and debugging.
  • Knowledgeable in ISO 13485: 2016 (or latest version) Medical Device Quality Management System Requirements.
  • Knowledgeable in ISO 14971: 2009 (or latest version) Risk Management.
  • Knowledgeable in FDA 21 CFR part 820 Quality System Regulations.
  • Knowledge of manufacturing and process development activities such as qualification, validation, design of experiments (DOE), and FMEA.
  • Advanced knowledge of and application of principles and theories of engineering.
  • Experience using SolidWorks for mechanical design a plus.
  • Proven ability to set and execute priorities in a timely manner.
  • Proven determination and resourcefulness to carry out complex projects through completion.
  • Demonstrated excellent oral and written communication, collaboration, and presentation skills.
  • Strong DOE, data analysis and documentation skills.
  • Ability to work both as an individual contributor and as a key member of the team.

 

Vaccination Requirement:

 

Due to the higher threat of more infectious and deadly COVID-19 variant strains emerging, Bio-Rad recently announced a new mandatory vaccination policy requiring its US employees to be fully vaccinated against COVID-19 as a condition of employment. Bio-Rad will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. With this policy, Bio-Rad joins a growing list of companies that are prioritizing sound science and available facts to best ensure the ongoing safety of its employees and the community.

 

About Bio-Rad:

 

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

 

Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

 

EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age

 

Agency Non-Solicitation: 

 

Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

 

 

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