Lead Medical Device Systems Engineer

ConvaTec Inc.; Manchester; Hybrid; GBP 100,000 - 140,000; Full time

Job summary

ConvaTec Inc. is seeking a Principal Systems Engineer to lead the systems engineering of our Advanced Wound Care pump system. You will integrate mechanical, electronic and firmware elements and work with internal and external partners to ensure robust, safe, and scalable product solutions.

This hybrid role starts at the Deeside site before relocation to Manchester, with regular collaboration across disciplines and supplier reviews to support verification, validation, and lifecycle management.

Qualifications

• Significant experience developing complex medical devices or other highly regulated electronic products.
• Strong systems engineering knowledge, ideally with electronics, electrical engineering, embedded systems or firmware background.
• Experience translating user and business needs into system requirements and technical specifications.
• Strong knowledge of requirements management, traceability and systems engineering methodologies.
• Experience supporting verification and validation activities at system level.
• Experience coordinating multidisciplinary technical teams, including mechanical, electronics and software/firmware.
• Ability to assess technical changes, understand their wider system impact and define the verification approach.
• Strong analytical and problem-solving skills; experience investigating complex technical issues.
• Confidence working with external development partners, manufacturers, suppliers and test facilities.
• Strong stakeholder management and communication skills; ability to explain complex technical information to non-technical audiences.
• An inquisitive and collaborative approach, with the confidence to ask questions and challenge assumptions.

Responsibilities

• Lead systems engineering across development and lifecycle management of complex electrical-mechanical devices.
• Translate user, clinical, regulatory and business needs into system requirements.
• Coordinate mechanical, electronic and firmware specialists for integrated systems.
• Develop and maintain system architectures, interface specs and technical docs.
• Establish traceability from user needs through design verification and validation.
• Lead system design reviews, risk assessments and engineering investigations.
• Manage technical changes involving the pump system and obsolescence.
• Collaborate with external partners to ensure changes are properly assessed and verified.
• Develop system-level verification and validation strategies and test criteria.
• Review test evidence and support laboratory, environmental and reliability testing.
• Support electrical safety, EMC, reliability and product performance activities.
• Contribute to ISO 14971 risk management activities.
• Support root-cause investigations, CAPAs and post-market improvements.
• Contribute to Design History Files and regulatory submissions.
• Partner with colleagues across engineering, clinical, quality and regulatory.

Skills

Systems engineering

Medical devices

Requirements management

Verification & validation

Cross-functional leadership

External partners

Stakeholder communication

Embedded systems

Electrical engineering

Firmware

Education

Bachelor’s degree or higher in Electrical Engineering, Electronic Engineering, Systems Engineering, Biomedical Engineering, Physics or another relevant technical discipline

Job description

ConvaTec Inc. is seeking a Principal Systems Engineer to lead the systems engineering of our Advanced Wound Care pump system. You will integrate mechanical, electronic and firmware elements and work with internal and external partners to ensure robust, safe, and scalable product solutions.

This hybrid role starts at the Deeside site before relocation to Manchester, with regular collaboration across disciplines and supplier reviews to support verification, validation, and lifecycle management.