Principal Systems Engineer

Description:

We’re looking for a Principal Systems Engineer to join our Advanced Wound Care R&D team and take technical ownership of the systems engineering activities supporting our negative pressure wound therapy portfolio.

This is an influential technical role focused on the electrical-mechanical pump system behind our wound care technology. You’ll bring together the mechanical, electronic and firmware elements of the product, working closely with internal specialists and the external partner responsible for its development and manufacture.

You’ll join at an important stage in the product lifecycle. A significant part of the role will involve supporting product launch and scale-up, managing planned changes and component obsolescence, and ensuring that the appropriate verification and validation work is completed. You’ll also help shape future generations of the technology by exploring how the product and system architecture could evolve.

This opportunity would suit an experienced systems, electronics or firmware engineer who enjoys understanding how complex products work, asking the right questions and coordinating specialists to reach safe, practical and technically robust solutions.

An exciting future in Manchester

Convatec has announced a major milestone in our R&D journey and our commitment to pioneering trusted medical solutions to improve the lives we touch. We have unveiled plans to relocate the majority of our UK-based R&D activities from Deeside to Manchester from late 2027/early 2028, alongside a significant expansion of our facilities in Boston.

The planned Manchester facility has the potential to become a major R&D hub within our global network. It will initially house global testing laboratories and advanced analytical R&D capabilities, while strengthening our collaboration with Manchester’s life sciences ecosystem, including universities, hospitals and research institutions.

Your key duties and responsibilities:

Lead systems engineering activities across the 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 the different elements of the product operate as an integrated system.
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 component substitutions and end-of-life parts.
Work closely with external development and manufacturing partners to ensure changes are properly assessed, documented and verified.
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 in accordance with ISO 14971.
Support root cause investigations, CAPAs, post-market improvements and product 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 supporting technologies.

Skills & Experience:

Essential

Significant experience developing complex medical devices or other highly regulated electronic products.
Strong systems engineering knowledge, ideally supported by a background in electronics, electrical engineering, embedded systems or firmware.
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 or firmware specialists.
Ability to assess technical changes, understand their wider system impact and define the appropriate verification approach.
Strong analytical and problem-solving skills, with experience investigating complex technical issues.
Confidence working with external development partners, manufacturers, suppliers and test facilities.
Strong stakeholder management and communication skills, including the ability to explain complex technical information to non-technical audiences.
An inquisitive and collaborative approach, with the confidence to ask questions, challenge assumptions and build effective working relationships.