Systems Engineer EU MDR - Remote
Posted on :
15-03-2024
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
15-03-2024
Job Description
Req ID : 2630773
For further inquiries regarding the following opportunity please contact one of our Talent Specialists
Sivanesan at
Divya at
Rashi at
Sivanesan at
Divya at
Rashi at
Title: Systems Engineer (EU MDR) Remote
Location: Remote (Candidate needs to be West Coast)
Duration: 1.5 Years
Location: Remote (Candidate needs to be West Coast)
Duration: 1.5 Years
Job Description:
We are seeking a highly skilled Contract Systems Engineer to join our team and support the development of our commercial medical devices.
We are seeking a highly skilled Contract Systems Engineer to join our team and support the development of our commercial medical devices.
The ideal candidate will have a strong understanding of INCOSE requirements engineering best practices and EARS requirements writing guidance.
Knowledge of EU MDR submissions and regulations
5 years of experience in requirements engineering with excellent understanding of INCOSE requirements engineering best practices and EARS requirements writing guidance
Trace requirements (hardware software and systems) to parent subsystems and systemlevel requirements.
Develop requirements trace matrices and verification trace matrices.
5 years of experience in requirements engineering with excellent understanding of INCOSE requirements engineering best practices and EARS requirements writing guidance
Trace requirements (hardware software and systems) to parent subsystems and systemlevel requirements.
Develop requirements trace matrices and verification trace matrices.
Responsibilities:
Follow INCOSE guide to write clear concise and testable requirements for hardware software and systems
Write rationale for each requirement user stories and test cases
Trace requirements to parent subsystem and system requirements
Create requirements trace matrix and verification trace matrix
Shadow other System Engineers to gain knowledge and experience
Support monthly software release cadence
Stay abreast of EU MDR submissions and regulations
Follow INCOSE guide to write clear concise and testable requirements for hardware software and systems
Write rationale for each requirement user stories and test cases
Trace requirements to parent subsystem and system requirements
Create requirements trace matrix and verification trace matrix
Shadow other System Engineers to gain knowledge and experience
Support monthly software release cadence
Stay abreast of EU MDR submissions and regulations
MustHaves:
Knowledge of EU MDR submissions and regulations
5 years of experience in requirements engineering with excellent understanding of INCOSE requirements engineering best practices and EARS requirements writing guidance
Trace requirements (hardware software and systems) to parent subsystems and systemlevel requirements.
Develop requirements trace matrices and verification trace matrices.
Knowledge of EU MDR submissions and regulations
5 years of experience in requirements engineering with excellent understanding of INCOSE requirements engineering best practices and EARS requirements writing guidance
Trace requirements (hardware software and systems) to parent subsystems and systemlevel requirements.
Develop requirements trace matrices and verification trace matrices.
Preferred Qualifications:
Experience with medical device development
Experience with agile development methodologies
Experience with requirements management tools (e.g. IBM DOORS Jama)
Experience with medical device development
Experience with agile development methodologies
Experience with requirements management tools (e.g. IBM DOORS Jama)
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the MidWest and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Employment Type
Remote
Key Skills
- Environment
- Academics
- Javase
- Cost Estimation
- Fire
- Business Studies
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