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Senior Test Engineer (Medical Devices)

Job Description

Direct Hire

Pay: $95 -120 K

SUMMARY:

Leading manufacturer of medical devices and software and a service provider for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. Their products are used in hospitals, clinics and laboratories worldwide. We for looking for a Senior Test Engineer to design, develop, and implements cost-effective methods of testing and troubleshooting systems and equipment for all phases of development and manufacturing. Prepare test and diagnostic programs, designs test fixtures and equipment, and completes specifications and procedures for new products. Plan the labor, schedules, and equipment required for testing and evaluating standard and special devices. Ensures all program are in compliance with good manufacturing practices (GMP).

ESSENTIAL DUTIES AND RESPONSIBILITIES for the Senior Test Engineer:

1. Complete assigned testing and providing technical know-how on complex to highly complex and particular products, operating systems and specialized environments by coordinating engineering activities for writing test procedures and developing test plans, configuring necessary hardware and operating environments; determining, developing, and implementing test automation implementation strategy and framework, product test plans, procedures, strategy documents, requirement traceability matrix (RTM) and other test documentation.

  • Confirm compliance by staying up-to-date and following all quality system procedures related to this job and assigned projects, which can affect the quality of products or services provided to our customers; maintaining currency and with evolving test engineering best practices and quality assurance lifecycle methodologies and processes as well as adhering to Medical Device companys' change control processes across all functional work activities.
  • Setup systems with desired configurations for test environments as outlined in the test process by coordinating all work activities for creating and maintaining effective, full-coverage manual test cases designed for automation using provided functional specifications and design documents; using various testing tools to automate the execution of new and existing test cases to test of complex to highly complex systems aggressively, review of found defects in the products under test; and document defects as they are discovered; participating in or leading defect reviews with test engineers and other teams; and coordinating work activities for configuring and maintaining test equipment at test station.
  • Meet all project schedule deadlines by planning individual workload and coordinating work activities of other engineers; participating in cross-functional teams during product development activities, continuous improvement activities, or troubleshooting activities ; and evaluating and determining approaches in development process for new projects during requirements evaluation and risk assessments.
  • Ensure the product meets customer needs by coordinating test reports and metrics for internal management and external review; providing issue analysis, evaluations and determinations for customer support, developers and other test team members; visiting customer sites and interfacing with customers to assess complex to highly problems; and executes manual test suites to and documents the results.
  • Identify, initiate, and execute process and product improvement projects by reviewing and providing feedback aimed at improving product requirements and designs; evaluating, determining, and implementing process improvement initiatives that increase product quality and team effectiveness; identifying, evaluating, and implementing test tools and strategies for meeting program verification and validation objectives; and interacting with external groups to expose testing risks, clarify requirements and designs, and review and approve test documentation.

Travel required: Slight travel is required (up to 10%).

Supervisory Responsibilities: May coordinate activities of less experienced engineers (this position is an individual contributor).

.

Job Requirements

QUALIFICATION REQUIREMENTS of the (Medical Devices) Senior Test Engineer:

  • Bachelor’s degree in systems , electrical or mechanical engineering
  • Minimum of 8 years of related experience ; or a Master’s degree and a minimum of 5 years of related experience; or a PhD with a minimum of 3 of experience.

Other Skills and Abilities of the Senior Test Engineer:

1. Basic programming skills in C++., Visual Basic, or .NET a plus.

  • Working knowledge of, and experience with CGMP, FDA QSR:21 CFR820 as applicable to Design Controls and Software Validation in a manner that assists software and hardware development and improves product quality.
  • Experience working with ISO standards such as ISO 13485 and ISO 14971.
  • Able to work with Networking environments and interfaces, components including a variety of servers a plus.
  • Interaction with Network traffic evaluation hardware and software for logging and feedback a plus.
  • Experience working with audio/visual computer components and accessories.
  • Prior test experience with complex systems and highly technical software.

Related Keywords: Test equipment, Test design, ISO 13485, and ISO 14971, Senior Test Engineer, C++, Test fixtures

Job Snapshot

Location US-WA-Seattle
Employment Type Full-Time
Pay Type Year
Pay Rate $95,000.00 - $120,000.00 /Year
Store Type Engineering
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Company Overview

AIC

Analysts International Corporation (AIC) is an IT services firm fully dedicated to the success and satisfaction of its customers. From IT staffing to project-based solutions, AIC provides a broad range of services designed to help businesses and government agencies drive value, control costs and deliver on the promise of a more efficient and productive enterprise. Learn More

Contact Information

US-WA-Seattle
Ronald Carpenter Jr
425-296-6348
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Snapshot
AIC
Company:
US-WA-Seattle
Location:
Full-Time
Employment Type:
Year
Pay Type:
$95,000.00 - $120,000.00 /Year
Pay Rate:
Engineering
Store Type:

Job Description

Direct Hire

Pay: $95 -120 K

SUMMARY:

Leading manufacturer of medical devices and software and a service provider for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. Their products are used in hospitals, clinics and laboratories worldwide. We for looking for a Senior Test Engineer to design, develop, and implements cost-effective methods of testing and troubleshooting systems and equipment for all phases of development and manufacturing. Prepare test and diagnostic programs, designs test fixtures and equipment, and completes specifications and procedures for new products. Plan the labor, schedules, and equipment required for testing and evaluating standard and special devices. Ensures all program are in compliance with good manufacturing practices (GMP).

ESSENTIAL DUTIES AND RESPONSIBILITIES for the Senior Test Engineer:

1. Complete assigned testing and providing technical know-how on complex to highly complex and particular products, operating systems and specialized environments by coordinating engineering activities for writing test procedures and developing test plans, configuring necessary hardware and operating environments; determining, developing, and implementing test automation implementation strategy and framework, product test plans, procedures, strategy documents, requirement traceability matrix (RTM) and other test documentation.

  • Confirm compliance by staying up-to-date and following all quality system procedures related to this job and assigned projects, which can affect the quality of products or services provided to our customers; maintaining currency and with evolving test engineering best practices and quality assurance lifecycle methodologies and processes as well as adhering to Medical Device companys' change control processes across all functional work activities.
  • Setup systems with desired configurations for test environments as outlined in the test process by coordinating all work activities for creating and maintaining effective, full-coverage manual test cases designed for automation using provided functional specifications and design documents; using various testing tools to automate the execution of new and existing test cases to test of complex to highly complex systems aggressively, review of found defects in the products under test; and document defects as they are discovered; participating in or leading defect reviews with test engineers and other teams; and coordinating work activities for configuring and maintaining test equipment at test station.
  • Meet all project schedule deadlines by planning individual workload and coordinating work activities of other engineers; participating in cross-functional teams during product development activities, continuous improvement activities, or troubleshooting activities ; and evaluating and determining approaches in development process for new projects during requirements evaluation and risk assessments.
  • Ensure the product meets customer needs by coordinating test reports and metrics for internal management and external review; providing issue analysis, evaluations and determinations for customer support, developers and other test team members; visiting customer sites and interfacing with customers to assess complex to highly problems; and executes manual test suites to and documents the results.
  • Identify, initiate, and execute process and product improvement projects by reviewing and providing feedback aimed at improving product requirements and designs; evaluating, determining, and implementing process improvement initiatives that increase product quality and team effectiveness; identifying, evaluating, and implementing test tools and strategies for meeting program verification and validation objectives; and interacting with external groups to expose testing risks, clarify requirements and designs, and review and approve test documentation.

Travel required: Slight travel is required (up to 10%).

Supervisory Responsibilities: May coordinate activities of less experienced engineers (this position is an individual contributor).

.

Job Requirements

QUALIFICATION REQUIREMENTS of the (Medical Devices) Senior Test Engineer:

  • Bachelor’s degree in systems , electrical or mechanical engineering
  • Minimum of 8 years of related experience ; or a Master’s degree and a minimum of 5 years of related experience; or a PhD with a minimum of 3 of experience.

Other Skills and Abilities of the Senior Test Engineer:

1. Basic programming skills in C++., Visual Basic, or .NET a plus.

  • Working knowledge of, and experience with CGMP, FDA QSR:21 CFR820 as applicable to Design Controls and Software Validation in a manner that assists software and hardware development and improves product quality.
  • Experience working with ISO standards such as ISO 13485 and ISO 14971.
  • Able to work with Networking environments and interfaces, components including a variety of servers a plus.
  • Interaction with Network traffic evaluation hardware and software for logging and feedback a plus.
  • Experience working with audio/visual computer components and accessories.
  • Prior test experience with complex systems and highly technical software.

Related Keywords: Test equipment, Test design, ISO 13485, and ISO 14971, Senior Test Engineer, C++, Test fixtures

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