Job Title: Systems Engineer Job Description Join a dynamic team as a Systems Engineering/Design Assurance contractor to ensure the success of an in vitro diagnostic system. This role requires expertise in requirements definition, risk management, technical writing, and familiarity with FDA & IVDR design control processes. Proficiency in MS Office tools and knowledge of DOORs and Agile tools are essential for success. Responsibilities + Contribute to sustaining engineering and design change projects by providing input, updates, maintenance, and reviews of associated requirements and product documentation. + Assist multidisciplinary development project teams in reaching goals through supporting IVDR review cycles, design reviews, requirement updates, generating trace matrices, and contributing to risk assessments, verification plans, and test protocols/reports. + Identify risks and propose mitigations for project incorporation. + Coordinate work across project teams and related groups, ensuring effective communication at all levels. + Expand understanding and employ 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 with applicable processes and work instructions. Essential Skills + Critical thinking and problem-solving skills + Requirements management experience (3-5 years) + Requirements writing experience + Collaborative personality who works well in teams + In vitro diagnostic experience + Medical device and design controls experience + Innovative thinker + Strong problem-solving skills + Familiarity with risk management Additional Skills & Qualifications + Experience with DOORs (IBM) + Project coordination skills + Experience with trace matrices + Verification and validation process experience Work Environment This role offers the flexibility of working fully remotely for candidates with strong skills. The ideal background includes experience in science engineering and familiarity with companies such as Abbott or Boston Scientific. Pay and Benefits The pay range for this position is $65.00 - $72.00/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 15, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.