Actalent
Systems Engineering/Design Assurance Contractor
Summary: 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 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. Skills: requirements definition, risk management, Design Controls Process, DOORs, Agile, IVDR, FDA, Technical Writing, Subsystems requirements Top Skills Details: requirements definition, risk management, Design Controls Process Additional Skills & Qualifications: Open to fully remote candidates if they have STRONG SKILLS Science engineering is most ideal Company experience such as Seimens, Abott, Boston scientific etc Red FLAG- short term experience 1 year or less Experience Level: Intermediate 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.
Summary: 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 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. Skills: requirements definition, risk management, Design Controls Process, DOORs, Agile, IVDR, FDA, Technical Writing, Subsystems requirements Top Skills Details: requirements definition, risk management, Design Controls Process Additional Skills & Qualifications: Open to fully remote candidates if they have STRONG SKILLS Science engineering is most ideal Company experience such as Seimens, Abott, Boston scientific etc Red FLAG- short term experience 1 year or less Experience Level: Intermediate 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.