Lead Systems Engineer, Wound Care Devices (Onsite)

BioCT Innovation Commons; North Haven (CT); On-site; USD 134,000 - 202,000; Full time

Benefits offered by this job

Health, dental and vision insurance

401(k) plan with employer match

Paid time off

Short-term incentive opportunities

Job summary

Medtronic in North Haven, CT is seeking a Principal Systems Engineer to lead systems engineering across wound management and hernia product families. You will drive requirements, risk management, verification, validation, and lifecycle activities while collaborating with R&D, Quality, Regulatory, Manufacturing, Marketing, and Released Product Engineering teams.

The role emphasizes technical leadership, cross-functional collaboration, and MBSE best practices to ensure product performance,

Qualifications

• Experience in regulated medical device development.
• Knowledge of design controls and product lifecycle processes.
• Experience leading cross-functional projects.
• Ability to work onsite in North Haven, CT.

Responsibilities

• Lead systems engineering activities across wound management and hernia product families, including requirements management, risk management, verification and validation planning, and lifecycle support.
• Establish and maintain intended use definitions, use cases, use conditions, stakeholder needs, design inputs, and end-to-end traceability across product and system requirements.
• Assess the impact of design, process, material, manufacturing, and labeling changes on launched products and product families.
• Drive technical investigations, root cause analyses, and cross-functional problem-solving activities to support product performance, quality, and regulatory compliance.
• Evaluate system-level risks, tradeoffs, and design decisions to ensure alignment with customer needs, product requirements, manufacturing feasibility, and business objectives.
• Apply systems engineering methodologies and best practices to improve consistency, efficiency, and technical rigor across the portfolio.
• Partner with Research and Development, Quality, Regulatory Affairs, Manufacturing, Marketing, and Released Product Engineering teams throughout the product lifecycle.
• Mentor and provide technical guidance to engineers and cross-functional team members on systems engineering processes, tools, and deliverables.

Skills

Systems engineering

Requirements management

Risk management

Verification & Validation

Design controls

Cross-functional collaboration

Leadership

Mentoring

Education

Bachelor's degree in Engineering

Master's degree in Engineering

PhD in Engineering

Tools

Model-based systems engineering

Requirements traceability

Job description

Medtronic in North Haven, CT is seeking a Principal Systems Engineer to lead systems engineering across wound management and hernia product families. You will drive requirements, risk management, verification, validation, and lifecycle activities while collaborating with R&D, Quality, Regulatory, Manufacturing, Marketing, and Released Product Engineering teams.

The role emphasizes technical leadership, cross-functional collaboration, and MBSE best practices to ensure product performance,