Medical Device Software jobs

Background:

Founded in 2020, Cerca Magnetics Limited’s (Cerca) goal is to make a real difference to people’s lives through technological advances. Working in partnership with The University of Nottingham and Magnetic Shields Limited, we have commercialised the world’s most advanced wearable functional brain scanner. Our device measures the magnetic fields within the brain using Optically-Pumped Magnetometers (OPMs) and due to its lightweight design can be worn by both adults and children whilst allowing them to move during a scan.

Following initial research-market sales, we are now progressing our technology toward release as a regulated medical device and building an ISO 13485-compliant design and development capability.

Description of the role:

As a Design Engineer (Medical Devices), you will help develop mechanical and physical product solutions for Cerca’s wearable OPM-MEG system, supporting the full product development lifecycle from concept through to design verification, validation support, design transfer and continuous improvement.This is a hands-on role for someone who enjoys solving complex engineering problems, working across disciplines, and creating robust designs suitable for manufacture, assembly, inspection, usability and regulatory scrutiny. You will work within an ISO 13485 design and development process, contributing to requirements, risk management, usability considerations, verification evidence and DHF-ready documentation.The role is suited to a capable engineer who has already worked through structured product development processes and is ready to take ownership of design activities within a growing medical-device environment.

Key role focus areas:

• Product design & development: Develop mechanical and physical product solutions for Cerca’s wearable OPM-MEG system, taking concepts through detailed design, prototype build, verification and release.
• Full lifecycle design ownership: Produce and maintain 2D/3D CAD models, manufacturing drawings, design specifications, tolerance analysis, material specifications and design-for-manufacture outputs.
• ISO 13485 design controls / DHF contribution: Work within Cerca’s ISO 13485 design and development process, ensuring design outputs are documented, reviewed, traceable and suitable for inclusion in the Design History File.
• Requirements & traceability: Translate user, system and product requirements into clear design inputs and outputs, maintaining traceability through to verification and validation evidence.
• Risk management: Contribute to risk management activities as designs evolve; identify design-related hazards and failure modes, implement appropriate risk controls, and ensure mitigations are verifiable and documented.
• Usability considerations: Consider usability throughout the design process, particularly where physical design, set-up, handling, adjustment, workflow or user interaction may impact safe and effective use.
• Verification & validation: Develop and support test plans, test procedures, design evaluations, prototype testing and verification reports, ensuring evidence aligns with requirements and identified risks.
• Design for Manufacture & Assembly: Apply DFMA principles to ensure designs are practical, repeatable, cost-effective and suitable for low-volume or scalable manufacture.
• Supplier, manufacturing & design transfer support: Work with suppliers, manufacturing, quality, regulatory, software and research teams to support build activities, manufacturing feasibility, design transfer, change control and product improvement.

Required skills & experience:

• Engineering degree (e.g., BSc/HND in Medical Engineering) or equivalent experience.
• Demonstrable experience including concept development, 3D CAD, detailed drawings, prototyping, testing, authoring/ maintaining, medical device product design and documentation (DHF content, risk management and usability documentation).
• Proficiency with 3D CAD software, ideally Onshape, Siemens NX or similar.
• Working knowledge of design controls (ISO 13485), risk (ISO 14971) and quality documentation practices.
• Strong written communication and attention to detail; able to balance compliance with a pragmatic engineering pace in a small company.
• Confident communicator able to work across design, technical, manufacturing and quality functions with various stakeholders.
• Ability to produce high-quality engineering documentation, including design specifications, drawings, calculations, test plans, test reports and design rationale.
• Good understanding of Design for Manufacture and Assembly, including tolerance analysis, material selection, manufacturing processes and supplier engagement.
• Self-motivated, pragmatic and comfortable working in a small, fast-moving engineering team.

Desirable (nice to have):

• Experience with FEA or other analytical tools, structural analysis, tolerance stack-up analysis or mathematical modelling.
• Experience with advanced manufacturing techniques, low-volume manufacturing, specialist materials or precision assemblies.
• Experience in magnetic shielding, sensing, low-noise environments, neuroimaging, scientific instrumentation or complex electromechanical systems.
• Familiarity with ISO documentation practices and standards (e.g., ISO 9001, IEC 60601).

What you will bring to Cerca

• Product development ownership — the ability to take ideas from concept into robust, documented and manufacturable designs.
• Medical-device mindset — an understanding that good design includes requirements, risk, usability, verification and traceability, not just CAD outputs.
• Practical engineering judgement — the ability to balance technical performance, manufacturability, usability, cost and regulatory expectations.
• Attention to detail — producing clear, accurate design outputs and documentation suitable for review, audit and future development.
• Collaborative energy — working closely with engineers, scientists, software specialists, quality, regulatory and manufacturing colleagues to solve complex problems.
• Passion for impact — helping make advanced brain-imaging technology more accessible and clinically useful.

In line with the Equality Act 2010, Cerca understands and appreciate the importance of equality, diversity and inclusion, both in work and in life. We therefore actively encourage applications from all backgrounds, as we believe a more diverse team is a more successful team! We look forward to hearing from you.

Job Type: Full-time

Pay: £35,000.00-£45,000.00 per year

Work Location: In person