Systems Engineer

New Yesterday

Title: IT Systems Engineer
Location: Boston, MA - Hybrid (open to fully remote for highly qualified candidates)
Pay: $80.00 - 89.05/hour bill rate
Duration: 6 Months+
Hours: Monday Friday; 8AM 5PM (40 hours/week)
Overview
The Systems Engineering/Design Assurance contractor will join a multidisciplinary team ensuring an in vitro diagnostic system meets its intended goals. The ideal candidate is experienced in requirements definition, risk management, technical writing, and FDA & IVDR design control processes. Proficiency with MS Office tools and familiarity with DOORs and Agile tools are preferred.
This role supports project teams by reviewing, updating, and maintaining product design and regulatory documentation. Work includes IVDR-related plans and reports, user needs, system/subsystem requirements, trace matrices, and labeling.
Job Description
Contribute to sustaining engineering and design change projects by updating and reviewing requirements and documentation
Support IVDR review cycles, design reviews, requirement updates, trace matrices, risk assessments, verification plans, and test protocols/reports
Identify risks and propose mitigations for incorporation into projects
Coordinate work across project teams and related groups
Communicate effectively with culturally diverse audiences and all organizational levels
Maintain compliance with Haemonetics Quality System processes and work instructions
Specific Tasks
Review and update plans, reports, labeling, user needs, system requirements, and trace matrices as needed
Manage and monitor execution of R&D quality plans and resolution of non-conformances
Support updates to requirements, risk assessments, and associated documentation for impacted products
Required Skills
3 5 years of requirements management experience
Requirements writing experience
Critical thinking and problem-solving skills
Collaborative, team-oriented personality
In vitro diagnostic experience
Medical device and design controls experience
Innovative thinking with strong problem-solving skills
Familiarity with risk management processes
Preferred Skills
DOORs (IBM) experience
Project coordination
Trace matrices
Verification and validation process experience
Experience with companies such as Company, Abbott, or Boston Scientific
Education Requirements
Bachelor s degree in a related science or engineering field preferred
Benefits (employee contribution):
Health insurance
Health savings account
Dental insurance
Vision insurance
Flexible spending accounts
Life insurance
Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Apply
Location:
Boston
Job Type:
FullTime

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