Principal Systems Engineer – Medical Devices (Hybrid)

Convatec; Manchester; Hybrid; GBP 100,000 - 135,000; Full time

Job summary

Convatec is seeking a Principal Systems Engineer for its Advanced Wound Care R&D team in the Manchester relocation program. You will own the systems engineering activities for the negative pressure wound therapy pump system, integrating mechanical, electronic and firmware elements with internal and external partners.

You will drive system architectures, verification and validation strategies, risk management and regulatory documentation, enabling product launches, scale‑up and lifecycle

Qualifications

• Significant experience developing complex medical devices or other highly regulated electronic products.
• Strong systems engineering knowledge with electronics, embedded electronics or firmware.
• Experience translating user needs into system requirements and specs.
• Knowledge of requirements management, traceability and systems engineering methods.
• Experience supporting system-level verification and validation.
• Experience coordinating multidisciplinary teams of mechanical, electronics and software/firmware.
• Ability to assess technical changes and verify impacts across the system.
• Strong analytical and problem-solving skills for complex issues.
• Ability to work with external development partners, manufacturers and test facilities.
• Good stakeholder communication to explain technical information to non-technical audiences.
• Collaborative approach and proactive questioning to drive robust solutions.

Responsibilities

• Lead system engineering across development and lifecycle management of complex electrical‑mechanical medical devices.
• Translate user, regulatory and business needs into system requirements.
• Coordinate mechanical, electronic and firmware specialists for integrated systems.
• Develop and maintain system architectures and interface specifications.
• Maintain traceability from user needs through verification and validation.
• Lead design reviews, risk assessments and investigations.
• Manage technical changes to the pump system and obsolescence.
• Collaborate with external development and manufacturing partners for changes.
• Develop system‑level verification and validation strategies and tests.
• Review test evidence; support lab, environmental, reliability and performance tests.
• Support electrical safety, EMC, reliability and product performance work.
• Contribute to ISO 14971 risk management activities.
• Support root cause investigations, CAPAs and post‑market improvements.
• Contribute to Design History Files, technical documentation and regulatory submissions.
• Partner with Electronics, Firmware, Mechanical, Clinical, Quality, Operations and Regulatory staff.
• Support supplier qualification and technical reviews.
• Provide technical guidance to project teams and coordinate internal and external work.
• Identify opportunities for future generations of the product.

Skills

Significant medical devices experience

Systems engineering knowledge

Requirements management

Matrix coordination

External partner collaboration

Analytical problem-solving

Stakeholder communication

Risk management (ISO 14971)

Verifications & validations

Regulatory contributions

Medical devices lifecycle

Active medical devices knowledge

NPWT / pump tech knowledge

Regulatory standards familiarity

Design History Files experience

Education

Bachelor’s or higher in Electrical/Electronic/Systems/Biomedical Engineering

Job description

Convatec is seeking a Principal Systems Engineer for its Advanced Wound Care R&D team in the Manchester relocation program. You will own the systems engineering activities for the negative pressure wound therapy pump system, integrating mechanical, electronic and firmware elements with internal and external partners.

You will drive system architectures, verification and validation strategies, risk management and regulatory documentation, enabling product launches, scale‑up and lifecycle