Systems Engineering/Design Assurance

Systems Engineer - Mechanical Systems / Product Development

Join our dynamic multidisciplinary team as a Systems Engineering/Design role. You will play a crucial role in ensuring that our system meets its intended goals. This position is ideal for someone experienced in requirements definition, risk management, technical writing, and familiar with DoD, design control processes. Proficiency in MS Office tools, DOORS, and Agile tools is essential.

Responsibilities

• Contribute to sustaining engineering and design change projects for input, update, maintenance, and review of associated requirements and product documentation.
• Support multidisciplinary development project teams to achieve team goals through IVDR review cycles, design reviews, requirement updates, and generation of trace matrices.
• Participate in risk assessments, verification plans, and test protocols/reports.
• Identify risks and propose mitigations for incorporation into the project.
• Coordinate work across project teams, related groups, or within the department.
• Communicate proactively and effectively at all levels, employing sensitivity in communications with culturally diverse audiences.
• Demonstrate knowledge of specialized disciplines and methods, supporting customer, operational policies, and processes.
• Complete all required training and maintain compliance to applicable processes and work instructions.
• Review and update plans, reports, and labeling as needed.
• Manage and monitor execution of R&D associated quality plans and resolve identified non-conformances.
• Evaluate and restructure User Needs/System Requirement documents.

Essential Skills

• Requirements management experience (3-5 years)
• Requirements writing experience
• Critical thinking and problem-solving skills
• Collaborative personality and ability to work well in teams
• Experience in in vitro diagnostics
• Experience in DoD and design controls
• Innovative thinking

Additional Skills & Qualifications

• Experience with DOORS (IBM)
• Project coordination experience
• Familiarity with trace matrices
• Experience with verification and validation processes
• Familiarity with Agile, IVDR, Technical writing, and subsystems requirements
• Science engineering experience is highly preferred

Work Environment

Hybrid work environment! Work alongside a diverse team using state-of-the-art technologies and equipment. The environment is fast-paced, collaborative, and focused on innovation, providing an engaging and supportive atmosphere.

Job Type & Location

This is a long term position based out of Massachusetts.

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)

Application Deadline

This position is anticipated to close on Oct 15, 2025.