inSync Staffing
Title:
IT - Systems Engineer 3 (SYS Team Contractor Systems Engineer) Pay:
$80.00 - 89.05/hour bill rate Hours:
Monday-Friday; 8AM-5PM (40 hours/week) Location:
Boston, MA 02110 (Hybrid - 125 Summer Street; open to fully remote for highly qualified candidates)
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.
IT - Systems Engineer 3 (SYS Team Contractor Systems Engineer) Pay:
$80.00 - 89.05/hour bill rate Hours:
Monday-Friday; 8AM-5PM (40 hours/week) Location:
Boston, MA 02110 (Hybrid - 125 Summer Street; open to fully remote for highly qualified candidates)
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.