Senior Systems Engineer (Medical Device)

Position Overview

We are seeking a Senior Systems Engineer for a very important client. This contract assignment is for 12 months and located in Minneapolis, MN. Compensation: Can Be Flexible!!

Key Responsibilities

• Collect and analyze design inputs (customer and business needs) and transform them into high-quality engineering requirements.
• Perform system architecture and design for all phases of development including concept, design, fabrication, test, installation, operation, maintenance, and disposal.
• Ensure the systematic conversion of system requirements and design into product requirements within technical, schedule, and cost constraints.
• Conduct functional analysis, timeline analysis, trade studies, requirements allocation, and interface definition studies to translate customer requirements into hardware and software specifications.
• Lead and document system analysis and design activities including architecture definition, interface management, performance modeling, system integration, and design failure modes and effects analyses.
• Identify technical development risks and execute risk burn-down plans.
• Facilitate cross-functional communication to drive design decisions, integration strategies, and resolution of technical issues.
• Verify system requirements have been properly implemented through inspection, demonstration, test, or analysis.
• Validate that implemented systems meet customer needs.
• Support regulatory body submissions and ensure smooth knowledge transfer to continuation engineering teams.
• Act as the primary contact for projects, liaising with internal/external customers and vendors; negotiate and influence decision-making when needed.
• Manage complex projects, delegate work, and review work products while providing team leadership.
• Provide guidance, coaching, and training to team members.
• Advocate for best practices and continuous improvement in Systems Engineering processes.
• Promote technology evolution and participate in developing system and product roadmaps.

Required Qualifications

• Advanced knowledge of the field, typically acquired through advanced education combined with practical experience.
• A University Degree with a minimum of 6 years of relevant experience, or an advanced degree with at least 3 years of relevant experience.

Preferred Qualifications

• Experience in system definition, design, requirements tracing, verification, and validation strategies.
• Previous medical device experience with a track record of bringing products from technology to market release.
• Expertise in designing hardware/firmware/communication interfaces of electronic devices.
• Experience troubleshooting firmware/software interfaces.
• Experience developing sensor-based systems, including closed-loop feedback control systems.
• Familiarity with developing data analytics and machine learning algorithms.
• Product Risk Assessment and Risk Management experience (e.g., Fault Tree Analysis, Failure Modes and Effects Analysis).
• Experience designing systems to meet ISO, IEC, and FDA regulatory requirements for medical systems.
• Strong verbal and written communication skills with the ability to make quick decisions and lead teams through complex issues.
• Experience working in cross-functional teams, particularly in FDA regulated and/or medical device environments.
• Experience interfacing with physician customers and therapy consultants.

Benefits & Perks

• MEC/ACP Medical
• Voluntary Dental, Vision, Life, Supplemental Income
• 401k (must meet requirements)
• Sick leave as required by state/county