Systems Engineer with Red FLAG

Hi,

Hope you are doing well.
My name is Rohen and I represent Vision InfoTech. I came across this role that you might be interested in. Let me know if you're interested in the below position.

Role: Systems Engineer with Red FLAG- short term experience like 1 year or less in recent project.

Location: Hybrid- Boston, MA-must be local

Job Type: Contract 6 months

Interview Type: Video

Required Skills:

Science engineering is most ideal

Company experience such as Seimens, Abott, Boston scientific etc.

Red FLAG- short term experience like 1 year or less in recent project

Job Description:

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.

Must haves:

Critical thinking and problem-solving skills

Requirements management experience, 3-5 years of experience

Requirements writing experience

Collaborative personality who works well in teams

Invitro diagnostic experience

Medical device and design controls experience

Innovative thinker

Strong problem-solving skills

Familiar with risk management and how it ties together with risk management

Doors (IBM)

Project coordination

Trace matrices

Experience with verification and validation processes

Thanks and Regards,

Rohen Singh

Talent Acquisition Specialist

VISION INFOTECH INC

Phone: .

Email:

368 Main Street, st#3, Melrose MA 02176

E-Verified Company