Senior Principal Systems Engineer

Jobtailor; Illinois; On-site; USD 130,000 - 180,000; Full time

Job summary

Jobtailor in the United States (Illinois) seeks an experienced engineering leader to own the technical roadmap for medical device programs and translate market needs into actionable requirements. You will drive system architecture across hardware and software domains, collaborating with Marketing, Clinical, and PM teams to deliver compliant, high-quality products.

You will guide risk management per ISO 14971, apply IEC 60601 safety standards, and lead multi-disciplinary teams using Agile SAFe.

Qualifications

• Bachelor’s degree in engineering or related field.
• 8+ years in medical device engineering.
• Experience applying risk management per ISO 14971.
• Knowledge of IEC 60601 safety standards.
• Ability to translate market needs into technical requirements.
• Proficiency with Agile SAFe and product owner support.
• Strong written and verbal communication.
• Experience with MBSE tools.

Responsibilities

• Own the technical roadmap for medical device programs.
• Translate market needs into technical requirements and workflows.
• Lead cross-functional teams including Marketing and Clinical.
• Define and scope projects with Engineering PM.
• Develop Design Inputs and Digital Interface Requirements.
• Own System Architecture and decomposition of requirements.

Skills

8+ yrs exp

ISO 14971

IEC 60601

Systems engineering

Agile SAFe

MATLAB/MBSE

Azure DevOps

Polarion/Trackwise

Leadership

Education

Bachelor's in Engineering

Tools

MATLAB

Azure DevOps

Polarion

Trackwise

Job description

Responsibilities

• Manage and own the technical roadmap for product families, integrate technical roadmaps with Upstream Marketing product roadmaps
• Work with Program Management, Upstream Marketing and Customers to plan new development, initiate product change activities, understand & translate market needs into technical product requirements & workflows
• Work with cross functional team members (e.g., Marketing and Clinical personnel) to translate user needs into system requirements
• Serve as liaison VOC from Marketing to Engineering
• Work with Engineering Project Management to define and scope projects to achieve program goals
• Participate as a member of project teams for the assigned program
• Lead development of Design Inputs and Digital Interface Requirements
• Develop User and Clinical Workflows to drive requirement analysis
• Own System Architecture
• Lead engineering resources (Electrical, Mechanical, and Software) in the decomposition of system requirements to derived requirements
• Contributes to resolution of competing constraints among inter-related functions (e.g., engineering, manufacturing, regulatory, marketing) required to deliver products to market
• Lead Decision Making using tools such as Decision Matrices to evaluate trade-offs
• Resolves interface issues and have the ability to document theory of operations of complex medical product designs
• Work with verification engineers to define test strategies for the development of verification plans and validation plans using requirement tracing methods
• Owner of the Design History File (DHF)
• Responsible for ensuring technical product requirements are clearly & thoroughly documented, and verified & validated
• This includes the following: Ensures usability requirements are adequately incorporated per IEC 62366
• Lead technical resource for Risk Management analysis activities per IEC 14971 including capturing hazards, mitigations, and residual risk determination
• Lead Coordination and review of system and design level requirements to ensure they adequately meet system requirements, market needs, serviceability and manufacturability of the product
• Member of multi-functional support team; duties as needed include serving as critical issue point-person, lead product support meetings, participate in CAPA activities, assist with complaint & post-market investigations
• Oversee platform-based product designs that meet needs for multiple portfolios by coordinating shared needs and requirements

Requirements

• Bachelor’s Degree (Mechanical, Electrical, Software, Biomedical Engineering or comparable technical subject area)
• 8+ years' of engineering experience on medical devices
• Knowledge in ISO 14971 Application of Risk Management to Medical Devices
• Knowledge of IEC 60601 Safety Compliance of Medical Devices
• Ability to apply systems engineering principles in Agile SAFe framework by supporting the Product Owner in Epic, Feature and Story development/definition and backlog prioritization
• Experience using tools such as MATLAB (MBSE), Azure DevOps, Polarion, Trackwise preferred
• Strong interpersonal skills with the ability to lead and work collaboratively with others in a team environment
• Able to work in the absence of complete information and make timely decisions performing with great attention to detail
• Excellent verbal and written communication, especially relating to clear, concise, and verifiable requirements
• Strategic problem solver, organized and able to progress on many different tasks in parallel
• Able to plan, estimate and accurately track deliverables
• Fundamental understanding of Hardware & Software engineering
• Adaptive, open to change and continuously looks for ways to improve and simplify sophisticated work
• Prior experience on Resting ECG devices (AFE, Cardiographs) is a plus.