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Remote Manufacturing Test Engineer Jobs in Illinois

Collaborate with cross-functional teams in developing test-driven system/functional requirements ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Data Quality Engineer

Downers Grove, IL · Remote

$114K - $137K/yr

... Remote-OH, Remote-PA, Remote-RI, Remote-VA Details Kemper is one of the nation's leading ... Test Automation and Reconciliation Design automated reconciliation processes between source and ...

Data Quality Engineer

Chicago, IL · Remote

$118K - $141K/yr

... Remote-OH, Remote-PA, Remote-RI, Remote-VA Details Kemper is one of the nation's leading ... Test Automation and Reconciliation Design automated reconciliation processes between source and ...

... test suites across a full-stack platform using Django, PostgreSQL, and React ... This hands-on, high impact and fully remote U.S. based role will have the opportunity to influence ...

Principal Engineer Controls

Chicago, IL · Remote

$109K - $159K/yr

You will provide technical leadership for manufacturing automation systems, identify opportunities ... This position is located in Omaha NE, Chicago IL, select field locations or remote locations east ...

Principal Engineer Controls

Chicago, IL · On-site +1

$109K - $159K/yr

You will provide technical leadership for manufacturing automation systems, identify opportunities ... This position is located in Omaha NE, Chicago IL, select field locations or remote locations east ...

Louis) While candidates in the listed locations are encouraged for this role, we are open to remote ... for the Manufacturing Segment of Databricks' Field Engineering organization. You will lead a ...

We are open to remote candidates. In this role, the Environmental Engineer is responsible for ... Understanding of CPG manufacturing processes and environmental impacts * Experience with Life Cycle ...

Remote Job Overview We are seeking experienced SolidWorks Specialists to contribute their expertise ... Reverse engineering (Scan-to-CAD). * Manufacturability analysis. * Python, iLogic, and VBA ...

Showing results 21-40

Remote Manufacturing Test Engineer information

What are the most commonly searched types of Manufacturing Test Engineer jobs in Illinois?

The most popular types of Manufacturing Test Engineer jobs in Illinois are:

Senior Quality Engineer

Tempus

Chicago, IL • On-site, Remote

Full-time

Re-posted 13 days ago


Job description

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

PLEASE NOTE: This is a hybrid role requiring three days a week in the office. Candidates can be based out of our Chicago (Headquarters), New York, or Redwood City locations.

As a Senior Quality Engineer, you will:

  • Lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s).

  • Lead risk assessments to determine testing strategies.

  • Be involved in the medical device software design controls activities, in accordance with the FDA Quality System Regulation, ISO 13485, GAMP5, Computer System Validation (CSV) standards and FDA guidance, other applicable regulatory requirements, as well as best practices in the software industry.

  • Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements.

Responsibilities:

  • Support regulatory compliance of the host system operating with Tempus Medical Device(s).

  • Develop and maintain CSV policies, procedures, templates and work instructions.

  • Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls activities.

  • Perform validation, re-validation and change controls of various AI, SaaS, and Tempus in-house developed software.

  • Author and review software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports.

  • Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution.

  • Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement.

  • Provide support to Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits.

  • Provide CSV guidance, coaching, mentorship, and training to test engineers within the team.

Qualifications

  • BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.

  • 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech)

  • 3+ years experience in Computer System Validation (CSV).

  • Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA (QSR) FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006).

  • Knowledge of quality system principles, practices, and standards for the life science industry.

  • Ability to deliver quality outputs without directions or under minimal supervision.

Chicago Pay Range: $90,000-$130,00

NYC/SF Pay Range: $100,000-$150,000

The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

Additionally,for remote roles open to individuals in unincorporated Los Angeles - including remote roles-Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.