Company:
Kestra Medical Technologies, Inc
Location: Kirkland
Closing Date: 06/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable technologies with proven device therapies. Kestra’s solutions combine high quality and technical performance with a wearable design that provides the greatest regard for patient comfort and dignity. Innovating versatile new ways to deliver care, Kestra is helping patients, and their care teams harmoniously monitor, manage, and protect life.
Responsible for developing and tracing tests for software and system verification for multiple projects. Work collaboratively with local and remote test engineers and development teams to identify and appropriately address design quality and reliability issues during development. Ensure compliance with all applicable Quality System requirements and the proper utilization of established best practices related to product level software test. Produce complete, concise, clear and technically correct work outputs. Actively participate in and contribute to improvements to design assurance processes and tools.
Requirements
ESSENTIAL DUTIES
Review and modify product design inputs for completeness, adequacy and testability
Develop test cases that ensure software and system meets product requirements
Develop, review, and execute software design verification protocols
Maintain traceability between requirements, test cases, and protocols
Create and track work tasks in project tracking software
Create and track issues in our issue tracking system
Generate progress reports for test coverage and other metrics
Technical document development and maintenance, including verification plans, reports, and test tool documentation
Compile software test results and create test reports
Participate in product test improvement initiatives, and provide technical contributions for the evolution of product test best practices
Work with limited supervision
COMPETENCIES
Passion: Contagious excitement about the company – sense of urgency. Commitment to continuous improvement.
Integrity: Commitment, accountability, and dedication to the highest ethical standards.
Collaboration/Teamwork: Inclusion of Team Member regardless of geography, position, and product or service.
Action/Results: High energy, decisive planning, timely execution.
Innovation: Generation of new ideas from original thinking.
Customer Focus: Exceed customer expectations, quality of products, services, and experience always present of mind.
Emotional Intelligence: Recognizes, understands, manages one’s own emotions and is able to influence others. A critical skill for pressure situations.
Ability to be a self-starter, seek new and better methods, and work with minimum supervision
Ability to collaborate within a Team environment and across functions
Capability to discern relevant facts and in turn, effectively resolve issues by making good decisions (compliance, quality, integrity, ethics, and critical thinking ability)
Ability to be flexible in a fast-paced goal-oriented environment
Demonstrates the understanding of deadlines and time limits, ability to accomplish goals, and the desire to win
QUALIFICATIONS
Education/Experience Required:
Bachelor’s degree or equivalent years of experience
3+ years of software test experience
Competency in Microsoft tools (Outlook, Excel, Teams)
Preferred:
Experience writing and executing detailed test cases, test plans, and test design documents
Experience with requirements management systems (IBM DOORS or similar)
Experience with issue and project tracking software (Jira or similar)
Experience in an externally regulated product development environment (FDA, FAA, etc.)
Familiarity with 21 CFR 820 regulations and ISO 13485, and 17025 medical device standards
Excellent technical writing skills and strong interpersonal communication skills
Familiarity with one or more computer scripting languages (e.g. Python)
WORK ENVIRONMENT
Indoor open office environment
Minimal noise volume typical to an office environment
Extended hours when needed
Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a condition of employment.
PHYSICAL DEMANDS
Frequent repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse usage
Frequent stationary position, often standing or sitting for prolonged periods of time
Frequent computer use
Frequent phone and other business machine use
Occasional lifting required, typically between 2-15 pounds
TRAVEL
Occasional travel may be required, less than 10%
Benefits
Kestra offers a very competitive benefit package including Medical, Dental, 401K with Match, etc.
Pay equity is an important part of Kestra’s Culture. Our compensation ranges are guided by national and local salary surveys and take into consideration experience level and internal equity. Each role is benchmarked based on the job description provided. If your qualifications and/or experience level are outside of the posted position, we encourage you to apply as we are growing fast and roles that are coming soon may not be posted.
Salary: Annualized between $100,000 - 110,000. Depending on experience and location.
Kestra Medical Technologies is an equal opportunity employer. Kestra Medical Technologies does not discriminate on the basis of race, color, religion, national origin, veteran status, disability, age, sexual orientation, gender identity and/or expression, marital status, or any other characteristic protected by law.
We are unable to sponsor or take over sponsorship of employment visas at this time. Applicants must be eligible to work for any employer in the U.S.
Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a condition of employment.
Responsible for developing and tracing tests for software and system verification for multiple projects. Work collaboratively with local and remote test engineers and development teams to identify and appropriately address design quality and reliability issues during development. Ensure compliance with all applicable Quality System requirements and the proper utilization of established best practices related to product level software test. Produce complete, concise, clear and technically correct work outputs. Actively participate in and contribute to improvements to design assurance processes and tools.
Requirements
ESSENTIAL DUTIES
Review and modify product design inputs for completeness, adequacy and testability
Develop test cases that ensure software and system meets product requirements
Develop, review, and execute software design verification protocols
Maintain traceability between requirements, test cases, and protocols
Create and track work tasks in project tracking software
Create and track issues in our issue tracking system
Generate progress reports for test coverage and other metrics
Technical document development and maintenance, including verification plans, reports, and test tool documentation
Compile software test results and create test reports
Participate in product test improvement initiatives, and provide technical contributions for the evolution of product test best practices
Work with limited supervision
COMPETENCIES
Passion: Contagious excitement about the company – sense of urgency. Commitment to continuous improvement.
Integrity: Commitment, accountability, and dedication to the highest ethical standards.
Collaboration/Teamwork: Inclusion of Team Member regardless of geography, position, and product or service.
Action/Results: High energy, decisive planning, timely execution.
Innovation: Generation of new ideas from original thinking.
Customer Focus: Exceed customer expectations, quality of products, services, and experience always present of mind.
Emotional Intelligence: Recognizes, understands, manages one’s own emotions and is able to influence others. A critical skill for pressure situations.
Ability to be a self-starter, seek new and better methods, and work with minimum supervision
Ability to collaborate within a Team environment and across functions
Capability to discern relevant facts and in turn, effectively resolve issues by making good decisions (compliance, quality, integrity, ethics, and critical thinking ability)
Ability to be flexible in a fast-paced goal-oriented environment
Demonstrates the understanding of deadlines and time limits, ability to accomplish goals, and the desire to win
QUALIFICATIONS
Education/Experience Required:
Bachelor’s degree or equivalent years of experience
3+ years of software test experience
Competency in Microsoft tools (Outlook, Excel, Teams)
Preferred:
Experience writing and executing detailed test cases, test plans, and test design documents
Experience with requirements management systems (IBM DOORS or similar)
Experience with issue and project tracking software (Jira or similar)
Experience in an externally regulated product development environment (FDA, FAA, etc.)
Familiarity with 21 CFR 820 regulations and ISO 13485, and 17025 medical device standards
Excellent technical writing skills and strong interpersonal communication skills
Familiarity with one or more computer scripting languages (e.g. Python)
WORK ENVIRONMENT
Indoor open office environment
Minimal noise volume typical to an office environment
Extended hours when needed
Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a condition of employment.
PHYSICAL DEMANDS
Frequent repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse usage
Frequent stationary position, often standing or sitting for prolonged periods of time
Frequent computer use
Frequent phone and other business machine use
Occasional lifting required, typically between 2-15 pounds
TRAVEL
Occasional travel may be required, less than 10%
Benefits
Kestra offers a very competitive benefit package including Medical, Dental, 401K with Match, etc.
Pay equity is an important part of Kestra’s Culture. Our compensation ranges are guided by national and local salary surveys and take into consideration experience level and internal equity. Each role is benchmarked based on the job description provided. If your qualifications and/or experience level are outside of the posted position, we encourage you to apply as we are growing fast and roles that are coming soon may not be posted.
Salary: Annualized between $100,000 - 110,000. Depending on experience and location.
Kestra Medical Technologies is an equal opportunity employer. Kestra Medical Technologies does not discriminate on the basis of race, color, religion, national origin, veteran status, disability, age, sexual orientation, gender identity and/or expression, marital status, or any other characteristic protected by law.
We are unable to sponsor or take over sponsorship of employment visas at this time. Applicants must be eligible to work for any employer in the U.S.
Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a condition of employment.
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