Overview
On Site
$70 - $80 hourly
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - Temp
Skills
Product Design
Systems Engineering
Documentation
Design Review
Risk Assessment
Collaboration
Training
Regulatory Compliance
Requirements Management
Business Requirements Gathering
Medical Devices
Design Controls
Risk Management
Critical Thinking
Conflict Resolution
Problem Solving
Artificial Intelligence
Messaging
Job Details
RESPONSIBILITIES:
Kforce has a client that is seeking a Systems Engineer in Boston, MA.
Summary:
This role will support project teams through review and/or update, and maintenance of product design and regulatory support documentation designated to Systems Engineering including but not limited to: IVDR related plans and reports, user needs, system, and subsystem requirements, associated trace matrices, and labeling.
General Responsibilities:
* Contributes to sustaining engineering and design change projects for input, update, maintenance, and review of associated requirements and product documentation
* Assists members of the multidisciplinary development project team to reach team goals through support of IVDR review cycles, design reviews, requirement updates, generation of trace matrices, and contributions to risk assessments, verification plans, and test protocols/reports
* Contributes to and helps Identify risks and proposes mitigations for incorporation into the project
* Coordinates work across project team(s), related groups, or within the department; Communicates proactively and effectively at all levels; Expands understanding and employs sensitivity in communications with culturally diverse audiences
* Demonstrates knowledge of specialized discipline and methods, and applicability to specialized product needs to support customer, operational policies and processes
* Completes all required training and maintains compliance to applicable Company's Quality System processes and work instructions
REQUIREMENTS:
* Requirements management experience, 3-5 years of experience
* Requirements writing experience
* Invitro diagnostic experience
* Medical device and design controls experience
* Familiar with risk management and how it ties together with risk management
* Critical thinking and problem-solving skills
* Collaborative personality who works well in teams
* Innovative thinker
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:
This role will support project teams through review and/or update, and maintenance of product design and regulatory support documentation designated to Systems Engineering including but not limited to: IVDR related plans and reports, user needs, system, and subsystem requirements, associated trace matrices, and labeling.
General Responsibilities:
* Contributes to sustaining engineering and design change projects for input, update, maintenance, and review of associated requirements and product documentation
* Assists members of the multidisciplinary development project team to reach team goals through support of IVDR review cycles, design reviews, requirement updates, generation of trace matrices, and contributions to risk assessments, verification plans, and test protocols/reports
* Contributes to and helps Identify risks and proposes mitigations for incorporation into the project
* Coordinates work across project team(s), related groups, or within the department; Communicates proactively and effectively at all levels; Expands understanding and employs sensitivity in communications with culturally diverse audiences
* Demonstrates knowledge of specialized discipline and methods, and applicability to specialized product needs to support customer, operational policies and processes
* Completes all required training and maintains compliance to applicable Company's Quality System processes and work instructions
REQUIREMENTS:
* Requirements management experience, 3-5 years of experience
* Requirements writing experience
* Invitro diagnostic experience
* Medical device and design controls experience
* Familiar with risk management and how it ties together with risk management
* Critical thinking and problem-solving skills
* Collaborative personality who works well in teams
* Innovative thinker
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.