Principal Systems Engineer

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

About the role

We’re looking for a

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.

Desirable

• Previous experience developing or supporting active medical devices.
• Experience with negative pressure wound therapy, pump technologies, sensors, actuators, power systems or embedded control systems.
• Knowledge of medical device design controls and lifecycle management.
• Experience managing electronic component obsolescence or component changes.
• Working knowledge of relevant standards and regulations, including:
  • ISO 14971
  • ISO 13485
  • IEC 60601 series
  • IEC 62304
  • IEC 62366
  • EU MDR, UK MDR or applicable FDA requirements
• Experience contributing to Design History Files, technical documentation or regulatory submissions.
• Experience supporting root cause investigations, CAPAs and post‑market product improvements.

Qualifications/Education

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

Travel Requirements

• Position may involve travel, mostly within Europe but international travel may be expected up to 25% of working hours. Some trips may include overnight travel.

Working Conditions

• The role will initially be based at our Deeside site before transitioning to Manchester as part of Convatec’s planned R&D relocation.
• This is a hybrid position. The current team generally works onsite three days per week, with flexibility to work remotely for one or two days depending on business and project needs.
• The role involves working across office, laboratory, pilot and production environments and may include supporting the manufacture of prototype medical devices.

Special Factors

• As Convatec is a multinational organisation, some flexibility may be required when collaborating with colleagues and technical partners across different locations.
• The role requires the ability to manage changing priorities, meet project deadlines and operate effectively during periods of increased workload.
• You’ll need to interpret complex technical information and communicate it clearly to both technical and non‑technical stakeholders.

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

About Convatec

Pioneering trusted medical solutions to improve the lives we touch

Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care and Infusion Care. With over 10,000 colleagues, we provide products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention, treatment for hard to heal wounds, at‑risk skin and ulcerated tissue to supporting debilitating conditions, improved patient outcomes and reduced care costs. Convatec's revenues in 2025 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit: http://www.convatecgroup.com.