Systems Engineer
Systems Engineer
Posted on :
14-08-2025
Employer Active
1 Vacancy
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Job Description
Job Summary (List Format):
- Support requirements management and writing activities for medical device (IVD) projects
- Apply 3-5 years experience in requirements management including documentation and traceability
- Collaborate with cross-functional teams to ensure effective requirements gathering and solutions
- Ensure compliance with FDA/IVDR design controls and regulations
- Utilize strong critical thinking and problem-solving abilities to address project challenges
- Participate in risk management and understand its integration with overall project requirements
- Leverage proficiency in MS Office; familiarity with IBM DOORs and Agile tools is desirable
- Coordinate with project teams and assist in project coordination tasks as needed
- Contribute to verification and validation (V&V) processes including trace matrices
- Demonstrate strong communication and teamwork skills in a hybrid work environment (Boston MA)
- Foster innovation and contribute ideas to improve processes and solutions
- Support requirements management and writing activities for medical device (IVD) projects
- Apply 3-5 years experience in requirements management including documentation and traceability
- Collaborate with cross-functional teams to ensure effective requirements gathering and solutions
- Ensure compliance with FDA/IVDR design controls and regulations
- Utilize strong critical thinking and problem-solving abilities to address project challenges
- Participate in risk management and understand its integration with overall project requirements
- Leverage proficiency in MS Office; familiarity with IBM DOORs and Agile tools is desirable
- Coordinate with project teams and assist in project coordination tasks as needed
- Contribute to verification and validation (V&V) processes including trace matrices
- Demonstrate strong communication and teamwork skills in a hybrid work environment (Boston MA)
- Foster innovation and contribute ideas to improve processes and solutions
Employment Type
Full-time
Key Skills
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