Overview
On Site
$70 - $80 hourly
Contract - W2
Contract - Temp
Skills
Attention To Detail
System Requirements
Risk Assessment
Documentation
Design Review
Collaboration
Regulatory Compliance
Requirements Management
Writing
Medical Devices
Design Controls
IBM Rational DOORS
Agile
Critical Thinking
Problem Solving
Conflict Resolution
Communication
Project Coordination
Artificial Intelligence
Messaging
Job Details
RESPONSIBILITIES:
Kforce has a client that is seeking a Systems Engineer in Boston, MA.
Summary:
We're looking for a detail-oriented contractor to help drive quality and compliance in the development of cutting-edge in vitro diagnostic systems. If you thrive in cross-functional teams and enjoy translating complex requirements into clear documentation, this role is for you.
What You'll Do:
* Systems Engineer will define and update user needs, system requirements, trace matrices, and labeling
* Contribute to risk assessments, verification plans, and test protocols
* As a Systems Engineer, you will support IVDR-related documentation and design reviews
* Collaborate across teams to ensure compliance and quality
REQUIREMENTS:
* 3-5 years of experience in requirements management and writing
* Background in medical device development and FDA/IVDR design controls
* Proficiency in MS Office; Familiarity with DOORs and Agile tools
* Strong critical thinking and problem-solving skills
* Team-oriented mindset with excellent communication skills
Bonus Skills:
* Project coordination
* Experience with trace matrices and V&V processes
The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.
We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.
Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.
This job is not eligible for bonuses, incentives or commissions.
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
By clicking ?Apply Today? you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers. Note that if you choose to communicate with Kforce via text messaging the frequency may vary, and message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You will always have the right to cease communicating via text by using key words such as STOP.
Kforce has a client that is seeking a Systems Engineer in Boston, MA.
Summary:
We're looking for a detail-oriented contractor to help drive quality and compliance in the development of cutting-edge in vitro diagnostic systems. If you thrive in cross-functional teams and enjoy translating complex requirements into clear documentation, this role is for you.
What You'll Do:
* Systems Engineer will define and update user needs, system requirements, trace matrices, and labeling
* Contribute to risk assessments, verification plans, and test protocols
* As a Systems Engineer, you will support IVDR-related documentation and design reviews
* Collaborate across teams to ensure compliance and quality
REQUIREMENTS:
* 3-5 years of experience in requirements management and writing
* Background in medical device development and FDA/IVDR design controls
* Proficiency in MS Office; Familiarity with DOORs and Agile tools
* Strong critical thinking and problem-solving skills
* Team-oriented mindset with excellent communication skills
Bonus Skills:
* Project coordination
* Experience with trace matrices and V&V processes
The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.
We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.
Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.
This job is not eligible for bonuses, incentives or commissions.
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
By clicking ?Apply Today? you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers. Note that if you choose to communicate with Kforce via text messaging the frequency may vary, and message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You will always have the right to cease communicating via text by using key words such as STOP.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.