About The Role

Working within our multidisciplinary teams on major software product development projects, you will be responsible for ensuring these comply with the highest quality and regulatory standards. Our software developments target both physical devices and “digital” (web, PC and mobile) applications, often in multi-disciplinary environments.

You will ideally have an excellent understanding of the Software as a Medical Device development process as well as direct past experience of writing product software; we find that this unique perspective will enable a deep appreciation of the needs of our software teams. You will need a very strong foundational understanding of why the regulations relating to software are written the way they are in order to support our project teams to best use our processes and procedures to fit the individual requirements of each project.

A fantastic time to join the team, you will have numerous projects to get stuck into and immediately add value. This role will suit an ambitious individual who is looking for career advancement and is keen to work with both ground-breaking new products from first concept and pre-existing products with significant past regulatory complexity. Positive, professional, and confident you will have the ability to attend client meetings and lead projects in the future.

 

About You

You will have:

Experience of submissions to regulatory authorities including EU, US and ROW

Experience of working within ISO 13485 quality management system, with a track record of continuous improvement relating to software development process

Experience of the regulations relating to medical software development in the US, EU and UK including working to ISO 62304 and other complementary international standards

Experienced at developing content for Risk Management Files as they relate to SaMD

Have a deep understanding of cybersecurity and privacy regulation across international borders

Able to support physical device development (including mechanical, electronic and software disciplines) and “digital” (web, PC and mobile) application development

Strong commercial awareness which translates into the ability to spot sales opportunities, write proposals, pitch and sell work to new clients (educating them where necessary) and attend conferences with a view to building up a client database

Great communication skills and the desire to use them to effectively transfer knowledge about software development throughout our business, and become a leader in the area of Software Quality at CDP

Ability to write technical documents in a methodical and timely manner

Excellent client management skills enabling the development of close client relationships

Desire to lead projects and programmes, taking responsibility for quality, time and profit

About Us
Cambridge Design Partnership (CDP) is an end-to-end innovation partner, propelling global brands and ambitious start-ups to success. We build breakthrough products and services – from insight to ideas, prototypes to production – bringing innovation to life. Our teams are multi-disciplinary, uniting scientific rigor, design ingenuity, and engineering excellence for consumer, healthcare, and industrial clients. People-centred, deeply collaborative, and – above all – expert, we’re uniquely positioned to shape the future for consumers, patients, and industry. Even our ownership model is innovative: We’re 100% owned by our employees, ensuring an open culture and a total commitment to our projects’ success. As part of our benefits package we offer:
 
  • flexible working 
  • a discretionary bonus
  • excellent learning and development opportunities
  • a 12% non-contributory pension
  • private healthcare
  • electric vehicle lease salary sacrifice scheme
  • share incentive plan
  • 25 days holiday plus bank holidays