Principal Systems Engineer – Medical Devices

Medtronic plc; North Haven (CT); On-site; USD 134,000 - 202,000; Full time

Benefits offered by this job

Health, Dental & Vision insurance

401(k) plan with employer match

Paid time off

Tuition assistance/reimbursement

Well-being program

Job summary

Medtronic plc in North Haven, CT is seeking a Principal Systems Engineer to provide technical leadership across wound management and hernia product families. You will drive requirements, risk management, verification and validation planning, and end-to-end traceability to support a large, globally launched portfolio.

You will mentor engineers, collaborate with R&D, Quality, Regulatory, Manufacturing, Marketing and Released Product Engineering, and ensure compliance and business continuity

Qualifications

• Bachelor's degree with 7+ years of engineering experience or higher degrees with relevant experience.
• Experience in a regulated product development environment with design controls.
• Ability to work onsite in North Haven, CT.
• Experience leading technical projects with cross-functional stakeholders.

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.
• Partner with R&D, Quality, Regulatory Affairs, Manufacturing, Marketing, and Released Product Engineering teams throughout the product lifecycle; mentor engineers.

Skills

Systems engineering leadership

Requirements management

Risk management

Technical leadership

Cross-functional collaboration

Root cause analysis

Education

Bachelor's degree in Engineering

Master's degree in Engineering

PhD in Engineering

Tools

Systems engineering tools

Requirements traceability

Job description

Medtronic plc in North Haven, CT is seeking a Principal Systems Engineer to provide technical leadership across wound management and hernia product families. You will drive requirements, risk management, verification and validation planning, and end-to-end traceability to support a large, globally launched portfolio.

You will mentor engineers, collaborate with R&D, Quality, Regulatory, Manufacturing, Marketing and Released Product Engineering, and ensure compliance and business continuity