Hybrid Principal Systems Engineer, Medical Devices

Convatec; Manchester; Hybrid; GBP 80,000 - 105,000; Full time

Job summary

Convatec is seeking a Principal Systems Engineer to own the systems engineering for our negative pressure wound therapy pump platform, integrating mechanical, electronic and firmware elements. The role leads cross-disciplinary teams, shapes architecture and verification strategies, and partners with external developers and manufacturers.

Based in Manchester as part of a planned R&D relocation from Deeside, the position is hybrid, with onsite presence and remote collaboration as required to meet

Qualifications

• Significant experience developing complex medical devices or highly regulated electronic products.
• Systems engineering knowledge with electronics, embedded systems or firmware background.
• Experience translating user and business needs into system requirements and technical specifications.
• Strong requirements management, traceability and systems engineering methodologies.
• Experience supporting verification and validation at system level.
• Experience coordinating multidisciplinary technical teams including mechanical, electronics and software/firmware.

Responsibilities

• Lead systems engineering across development and lifecycle management of complex electrical-mechanical medical devices.
• Translate user, clinical, regulatory and business needs into clearly defined system requirements.
• Coordinate mechanical, electronic and firmware specialists to ensure integrated system operation.
• Develop and maintain system architectures, interface specifications, requirements and technical documentation.
• Establish and maintain traceability from user needs through design verification and validation.
• Lead system design reviews, technical risk assessments and complex engineering investigations.
• Manage technical changes involving the pump system, including substitutions and end-of-life parts.
• Work with external development and manufacturing partners to verify changes.
• Develop system-level verification and validation strategies, test requirements and acceptance criteria.
• Review test evidence and support laboratory, environmental, reliability and performance testing.
• Support design activities relating to electrical safety, EMC, reliability and product performance.
• Contribute to risk management activities per ISO 14971.
• Support root cause investigations, CAPAs, post-market improvements and lifecycle activities.
• Contribute to Design History Files, technical documentation and regulatory submissions.
• Partner with colleagues across Electronics, Firmware, Mechanical Engineering, Clinical, Quality, Operations and Regulatory Affairs.
• Support supplier selection, component qualification and technical reviews.
• Provide technical guidance to project teams and coordinate work across internal specialists, external partners and third-party suppliers.
• Help identify and scope opportunities for future generations of the product and its technologies.

Skills

Systems engineering

Electrical engineering

Embedded systems

Firmware

Regulatory compliance

Stakeholder management

Vendor coordination

Risk assessment

Education

Electrical/Electronic/Systems Engineering degree

Biomedical Engineering degree

Tools

ISO 14971

ISO 13485

Job description

Convatec is seeking a Principal Systems Engineer to own the systems engineering for our negative pressure wound therapy pump platform, integrating mechanical, electronic and firmware elements. The role leads cross-disciplinary teams, shapes architecture and verification strategies, and partners with external developers and manufacturers.

Based in Manchester as part of a planned R&D relocation from Deeside, the position is hybrid, with onsite presence and remote collaboration as required to meet