Case Study 29th November 2021
Medical 3D model saves crucial time in heart transplant surgery for a patient with congenital heart disease
Abdel Hakim Moustafa is a Cardiologist and specializes in advanced cardiac imaging. He works at…
Join the Axial3D team
We're a dynamic team in the fast growing MedTech industry who are committed to making a difference
Grow your career with us
Starting with the simple goal of helping surgeons plan more effectively for complex procedures has quickly transformed into a global company that is changing how surgery is delivered around the world.
Our mission is to democratise the use of 3D imaging and modelling by surgeons to allow them to tailor treatment to their patients. This mission is made possible by our unique Segmentation-as-a-Service™ platform that converts 2D medical scans into highly accurate 3D files that can be viewed online or 3D printed. To date, we have worked with hundreds of surgeons and over 40 medical device companies in 30 countries around the world.
Depending on the role, you will work closely with your team and various departments towards our company goals. You will enter a lively and flexible workspace where no two days will be the same. Our headquarters are in Belfast, Northern Ireland, but our international team is based all over the world.
Benefits
Flexible working
Generous annual leave allowance
Company pension
Potential to earn stock options
Personal development
Unlimited tea and coffee
"Working at Axial3D is amazing for many reasons, but my favourite is how unique each day is and how rewarding our work is.
Every day presents new exciting challenges, and knowing that our work is benefiting the patient by enhancing surgical outcomes and boosting communication between the surgeon and the patient is an incredibly rewarding feeling."
Sarah Iannucci, Medical Visualization Engineer
"If you want a wonderful work-life balance, caring employers, and you want to work for a company striving to change as many lives as possible, Axial3D is the place for you."
Marissa Hight, US based Medical Visualization Engineer
"Through working with Axial3D you really feel the work you do can make a difference to a patient's life. The company is constantly evolving to deal with the advances in technology and 3D printing, so anything could happen! Axial3D always gives everyone equal opportunities to learn more and advance professionally into a role you enjoy!"
Cameron Auld, Senior Process Engineer
"The team assembled at Axial3D is my favourite part of working there. They are so easy to get along with and I have such good craic with them in and out of the office. They also made me feel so welcome when I first joined the company and made sure I had plenty of help in finding my feet."
Andrew Kelly, Administrative Research Assistant
"The vision that Daniel Crawford had 7 years ago to transform how surgery is delivered throughout the world, and the impact this has had on past and future patients. I have always been interested in the medical field and to listen to the various case studies on how the work at Axial3D has positively impacted patients, surgeons and families is truly remarkable.
Robbie Diack, Sales and Business Development Lead - EMEA
"At Axial3D we are operating in uncharted territory developing a service that simply does not exist in the World today. If you crave the freedom to do what you think is best, and have the discipline to deliver what you think is best, then a career at Axial3D is for you."
Tim Cooke, Software Architect
Senior QA/RA Associate
Axial3D is a leading provider of advanced medical imaging software solutions. Our cutting-edge technology is transforming the healthcare industry by enabling healthcare professionals to visualize and analyze medical imaging data in a more efficient and effective manner.
Headquartered in Belfast, Northern Ireland Axial3D provides solutions to over 300 hospitals, medical device manufacturers, and other healthcare companies around the world. Specializing in the delivery of 3D printed anatomical models and 3D visualizations and services to the healthcare sector, Axial3D provides machine learning-based solutions that support the integration of 3D patient-specific solutions into surgical care pathways and scaling patient-specific programs.
Ideal location for the position would be in Belfast.
The Role
As a senior QARA you will be responsible for improving and assisting implementation of the Axial3D Quality Policy and Procedures to facilitate company certification and compliance with ISO certifications. As Senior QA/RA Associate, you will work closely with the Quality Assurance and Regulatory Affairs team to improve processes and compliance of the Information Security and Quality Management System (IS & QMS).
You will promote awareness of the quality and customer requirements throughout the company, particularly with the Operations and Software Development teams responsible for producing patient-specific 3D anatomical models and files.
You will assist with the following:
- Ensure documentation of the processes needed for the support of quality management are in place
- Report on the performance of the QMS
- Report and manage NCR, CAPA and Change Controls identified within the company
- Assist with internal, external and supplier audits as required
- Reviewing and providing input to Post Market Surveillance and Vigilance processes
- Developing awareness and adoption of applicable standards throughout the organization
You will also be responsible for:
- Assisting and reviewing Medical Device Files, Technical Documentation and Device Master Records as required
- Maintain an up-to-date awareness of relevant legislation which may impact the QMS
- Facilitate productivity, process improvements and effectiveness across the organization
- Provide training sessions to ensure the understanding and compliance of all staff
- Promote the benefits of the quality system to all staff
- Facilitate and support the software engineering team with production of compliant Software as a Medical Device (SaMD) including
- Facilitate and support the Operations Team to ensure processes are in place for the controlled production of custom made patient specific 3D anatomical models and files
- Perform final QA release checks on products in preparation for dispatch
For this opportunity you should have:
- Experience of working with ISO 13485 including lead auditor certification is essential
- Minimum of 5 years experience working in a similar role in the medical device industry
- Experience in generation of technical documentation
- Awareness of medical device regulatory requirements including Medical Device Regulation (MDR) and FDA
Education Requirements:
- Bachelor's degree (or above) in a scientific or technical discipline
- Lead Auditor Qualified
Other Requirements:
- Strong communication and organizational skills
- Knowledge of ISO 14971, IEC 62304 and IEC 62366
- Awareness of Data and Information Security principles
- Awareness of global regulatory submissions and market access requirements
Axial3D is a rapidly growing and award-winning start-up and its success is built on the desire, determination, and talent of its employees. It’s a fun and growing team and Axial3D offers the opportunity for your ideas to be implemented and to be recognized and rewarded for your achievements. We are a diverse group of people committed to making a real impact on people’s lives. We build products for everyone and do not discriminate on gender, ethnicity, sexual orientation, religion, civil or family status, age, disability, or race.
Product Manager
Ready to shape the future of MedTech, working with the latest SaaS technologies to transform patient care?
Axial3D are recruiting a Product manager to join our digital product team with an experienced and expanding engineering team already in place.
As an Axial3D Product Manager, you will be working with agile multidisciplinary teams to create, support and continuously improve products that meet real user needs. You may be taking a product team through discovery, alpha, beta and live phases of development, or scaling a mature service, with the goal of making Axial3D services simpler, more accurate, and easier to use. This is a fantastic opportunity to demonstrate and develop your product management skills and experience. Product Managers at Axial3D work on exciting products in support of services that are relevant to every patient and clinician in the world. It is an opportunity to work with committed and talented developers, Medical Visualisation engineers, and clinical teams who share a vision for making healthcare better through smarter use of technology.
The Company
Axial3D is headquartered in Belfast, Northern Ireland and provides solutions to over 300 hospitals and other healthcare companies around the world. Specializing in the delivery of 3D anatomical model software and services to the healthcare sector, Axial3D provides cutting edge cloud-hosted, machine learning-based solutions that support the integration of 3D models into surgical care pathways, transforming surgical outcomes for patients.
The Role
As a Product Manager you will be:
- Working with a multidisciplinary team to deliver the product and iteratively improve it through several cycles.
- Working closely with the wider Product team, and in line with Axial3D Product Strategy, to determine prioritisation - ensuring we are building the right things at the right time in response to the market and our user needs.
- Developing an expert understanding of the users’ needs - Clinical, Patient and Operational and championing these in the delivery of your product.
- Developing and prioritising a product backlog, scoping and writing user stories, and making data-driven decisions.
- Deciding how a team’s time should be divided between new features, improvements to existing features, and operational support of a live product.
- Engaging with users and stakeholders through a range of channels from early research to design validation.
- Identifying and measuring what success looks like for your product and reporting against these to demonstrate value delivered to end users.
- Managing and maintaining key Product documentation in line with ISO 13485 and Axial3D internal Quality Management System.
- Driving quality and continuous improvement through the product delivery process.
- Supporting the vision, roadmaps and delivery of other products in Axial3D.
Who you are
We’re looking for someone who can demonstrate product management skills and experience. You will be an individual with strong interpersonal skills, who likes working in a delivery focused, agile environment with multidisciplinary teams. You will be someone who takes pride in representing users and enjoys the challenge of promoting the products you and your team are developing and operating.
For this opportunity you should have:
- Minimum of 3 years experience developing and releasing digital products with proficiency in agile product management techniques, such as user story writing, MVP definition and backlog prioritisation.
- Thorough understanding of a variety of disciplines involved in digital delivery, including engineering, service design, performance analysis and user research, developed through working in multidisciplinary teams.
- Experience of engaging with users and using qualitative and quantitative data to identify how their needs can be met by products and services
- Experience working in teams delivering SaaS or Cloud-based product(s).
- Effective verbal, written and visual communication skills that you are able to tailor to the needs of the audience.
Desirable
- Previous experience working in a medical software or medical device company.
- Previous experience in teams delivering product(s) leveraging Machine Learning solutions.
- Previous experience in an early or mid-stage company.
The opportunity
Axial3D is a rapidly growing and award-winning start-up and its success is built on the desire, determination, and talent of its employees.
It’s a fun and growing team and Axial3D offers the opportunity for your ideas to be implemented and to be recognized and rewarded for your achievements. We are a diverse group of people committed to making a real impact on people’s lives. We build products for everyone and do not discriminate on gender, ethnicity, sexual orientation, religion, civil or family status, age, disability, or race.
How to apply
Apply via email
Send your CV and cover letter to careers@axial3d.com so we can get to know you better.
We will get back to you as soon as we can to discuss the next steps.
Can't see any job openings?
We would still like to hear from you. Send your CV to careers@axial3d.com and we will get back to you as soon as possible.
