Description
\t\t\t\t\tSummary:Systems Engineering/Design Assurance contractor will work alongside a multidisciplinary team responsible for ensuring an in vitro diagnostic system meets its intended goals. The person in this role is experienced in requirements definition, risk management, technical writing, as well as FDA & IVDR design control processes. The ideal candidate is proficient in all MS office tools and familiar with both DOORs and Agile tools. 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 Haemonetics Quality System processes and work instructions Specific Tasks: Responsibility Review plans and reports, as applicable Update Analytical Performance Reports, as needed Manage & monitor execution of R&D associated quality plans and resolution of identified non-conformances Support evaluation and restructuring of User Needs/System Requirement documents. Support definition and updates to requirements for 1.10 SW and associated trace matrices, as needed Support review and update of labeling, as needed Support definition and updates to requirements and associated trace matrices, as needed Support definition and updates to requirements, associated trace matrices, and review of labeling updates as needed Support definition and updates to user needs, requirements, risk assessments, associated trace matrices, and labeling as needed. Support definition and updates to user needs, requirements, risk assessments, associated trace matrices, and labeling as needed. Support updates to requirements, associated trace matrices, and any other impacted product documentation, as needed.
\t\t\t\t\tSkills
\t\t\t\t\trequirements definition, risk management, Design Controls Process, DOORs, Agile, IVDR, FDA, Technical Writing, Subsystems requirements
\t\t\t\t\tTop Skills Details
\t\t\t\t\trequirements definition,risk management,Design Controls Process
\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\tAdditional Notes:Open to fully remote candidates if they have STRONG SKILLSScience engineering is most idealCompany experience such as Seimens, Abott, Boston scientific etcRed FLAG- short term experience 1 year or less
\t\t\t\t\tExperience Level
\t\t\t\t\tIntermediate Level
Pay and Benefits
The pay range for this position is $65.00 - $75.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Boston,MA.
Application Deadline
This position is anticipated to close on Aug 22, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.