Systems Engineer

Growing company in Waltham is seeking a Staff Systems Engineer for a 3+ month contract assignment. The proper candidate should have knowledge of Med Device Standards, specifically 60601-1. The candidate should have experience working as a Systems Engineer through all the V&V process, on medical/surgical robots, medical capital equipment, or medical single use. The proper should have exposure to statistical techniques as it relates to sampling and generating technical reports. Experience working through FDA submissions/audits would be a big plus. The role offers a great contract rate with the potential to extend. Apply today, we'd love to meet you!

Staff Systems Engineer (3-month contract, possibility to be extended)

As a Staff Systems Engineer you will contribute to all aspects of system-level design, integration, testing, and medical device design controls.

The Systems Engineering group is a cross-functional team that is responsible for delivering detailed design material covering all aspects of the surgical robotic platform under development. As a member of this team, you will work closely with engineers in various disciplines, as well as clinical development, and marketing to support the rapid development of innovative technology.

Responsibilities

• Interface with key stakeholders, including marketing and surgeons, to translate evolving market needs to refined system and subsystem requirements.

• Perform functional analysis and decomposition, develop and manage product requirements, and refine system and subsystem architectures.

• Engage with design quality assurance in risk management activities, including risk assessment and risk mitigation strategies.

• Assist in driving compliance with standards including IEC 60601-1, ISO 14971, ISO 13485, and IEC 62366-1.

• Oversee regulated development processes and standards for risk management, useability, and safety to ensure system design and documentation meet relevant safety and regulatory standards.

• Collaborate with Core Teams and Project Management to meet strategic goals and deliverables.

• Opportunities to mentor and coach junior engineers on best practices and strategies.

Skills/Experience

• Minimum of a BS in an engineering discipline (Systems, Mechanical, Electrical, Computer Science, etc).

• 8+ years of experience in the medical device industry working on complex electromechanical systems (robotics preferred).

• Deep understanding of structured product development cycle (requirements-driven engineering, documentation, rigorous verification).

• Broad knowledge of 1st principles across multiple engineering functional domains (electrical, mechanical, software).

• Highly organized and independent - able to self-manage priorities to meet timelines.. ? Demonstrated track record of successfully driving complex projects to completion.

• Personable team player - able to work directly with individuals with varying skills and experiences.

• Strong verbal and written communication skills - able to precisely articulate complex technical concepts and generate persuasive and comprehensive presentations.

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