Head of Engineering (Medical Device Development)

ADLIB Recruitment has partnered with GenomeKey in the search for their Head of Engineering. GenomeKey is a Bristol-based biotechnology scale-up developing a medical diagnostic device that will reduce the time taken to determine how to treat sepsis from days to hours. Our device will combine state of the art science and technology to deliver results at an unprecedented accuracy and speed. This will save lives, save money, and advise the most effective and efficient use of antibiotics.
  
As the Head of Engineering, you will be leading Product Development and have previous experience of working on developing a medical diagnostic or device. The candidate will be joining our team developing a prototype device which will follow onto clinical testing and finally manufacture. As the Head of Engineering, you will play a vital leadership role, overseeing all engineering disciplines within our dynamic and fast-paced organisation.
 
You will play a key role in the design, integration, and manufacture of our system. Your responsibilities will include:

• Take full ownership of Product Engineering, including device development, software integration, CAD and BOM.
• Lead the technical planning for the device and cartridge, and be “hands-on” in the lab/workshop to support practical development activities.
• Drive the design and engineering development of internally and externally sourced parts and assemblies.
• Coordinating between and leading the delivery of scientific/development teams and key stakeholders to meet product requirements
• Develop engineering policies and strategies, including the appraisal and selection of new technologies.
• Implement and enhance best practices in engineering tools and techniques.
• Provide staff training and development opportunities.
• Foster industrial and academic partnerships, nurturing relationships and exploring collaboration opportunities.
• Ensure product safety and compliance with legislative and regulatory frameworks.
• Drive manufacturing process development, product launch, and continuous improvement activities.
• Lead and inspire the engineering team, promoting a high-performance and quality-conscious culture.
• Champion health and safety initiatives related to engineering activities and engage with stakeholders across the site.
• Develop and manage key performance indicators (KPIs) to drive performance and ensure success.
• Developing the IVD under a Quality Management System in accordance with ISO 13485 and ISO 14971.
• Provide technical support to key stakeholders throughout the value chain.
• Designing IVD instrument to allow for future scaled, cost-effective manufacturing.

Person Specification:
 
We are looking for you to have a passion for creating devices, components and working with cross-functional teams to find engineering solutions to a range of technical challenges. You will have an enthusiasm for applying fundamental engineering principles to innovative problem solving. You will embrace working within a mixed scientific team of biologists, microfluidics scientists and computer scientists, to develop new medical technologies.
 
If you have excellent communication skills, you are able to share complex ideas at varying levels of technical depth, this role is for you! You will have a desire to work in a startup ecosystem, embracing learning on the job and adapting to new challenges.
 
Qualifications & Experience
 
You should aim to meet the majority of the following skills and experiences, however candidates with varied backgrounds will be considered for this role.
 
Essential

• Master’s or Ph.D. degree in an engineering discipline, such as mechanical, electrical or biomedical engineering, or equivalent experience.
• 6+ years industry experience of developing complex products or medical devices.
• Hands-on experience in design, build and test of electromechanical systems such as mechanical hardware, electronics, software, pneumatics, pumps, thermal, optical and biocompatible materials, managing the interfaces between instrument and reagent disposable devices.
• Ability to develop plans and schedules for a complex project and adhere to them through to completion.
• Experience leading an engineering team.
• Prior experience coordinating between different scientific and technical development teams – including both software and hardware – to achieve product development goals.
• Practical hands-on prototyping/fabrication experience using methods such as CNC milling, 3D printing, laser cutting, plastic diffusion bonding and injection moulding.
• Proven ability to analyse and communicate experimental results clearly to internal and external stakeholders.
• Experienced user of SolidWorks or similar CAD software.
• Experience and willingness to adopt a fail fast iterative approach to developing prototypes.
• Excellent communication skills, verbal and written.

Desirable

• 8+ years industry of life sciences instrumentation, IVD, or medical device space.
• Experience with IVD or Life Science instrumentation development used for processing and analysing blood.
• Familiarity with common blood and urine analysis techniques including flow cytometry, coulter, ISE, and spectrophotometry.
• Knowledgeable in electrical circuit design, robotics and fluidic systems.
• Prior experience with design for manufacturing.
• Prior experience developing a product under Design Controls, particularly an ISO-13485-compliant Quality Management System.

Company Benefits
 
GenomeKey is a startup company offering the following employment benefits:

• Competitive salary dependent on experience.
• Pension contributions.
• Flexible working around core hours.
• Remote working from home available, according to business need.
• Commitment to your personal development in a dynamic startup company.
• Working as part of a friendly and supportive team.

 GenomeKey welcomes individuals with a broad range of expertise and experiences, diverse careers and backgrounds. As an equal opportunity company, we endeavour to anonymise applications and strip them of any protected information prior to review.
 
How to apply for the role?

If you are interested in the Head of Engineering role at GenomeKey then feel free to apply to the advert or get in touch with Zoe Davies on LinkedIn or email on zoe@adlib-recruitment.co.uk.