You know the Software as a Medical Device (SaMD) market is on the crest of a wave, with huge growth potential. But is your current role the best platform to take advantage of that?

Are you working with medical experts on therapeutic solutions spanning human and animal health? Are you developing products for different global markets?

Are you using the latest technology, the sharpest market research, the best quality data? Are you trusted to shape strategy and make decisions?

This new role, helping a global Top-20 pharma business to launch their new Medical Device Software venture, offers you all those things and more.

The challenge

As Principal Quality Engineer, you’ll join the Software Engineering Chapter of the company’s digital lab and set the pace for SaMD product development from the very start.

As one of the first senior members of this new venture for the business, it’s a chance to make a huge personal impact. There’s no existing hierarchy – you’ll shape the way everything works, setting quality standards for the entire software development lifecycle. You’ll develop a team that’s equipped to develop high-quality products, following best practice methodology and medical regulations.

It’s a role with huge scope; you’ll play a key role as a technology and quality process leader, ensuring that the products can be scaled across different continents and many specialist therapeutic areas, such as heart disease, diabetes and respiratory.

Your role will see you work closely with colleagues across software engineering, senior leadership and external vendors. You’ll also guide and mentor junior colleagues.

What you can add

You’ve done this successfully before. You’re a proven lead quality engineer who’s directed product development and quality processes related to Software as a Medical Device products (class II and/or class III). You’ve co-ordinated large projects across multiple entities and countries, demonstrating strong communication skills.

Beyond that, we need to see as many of the following points on your CV:

• Good knowledge of relevant regulatory standards, such as EU Medical Device Directives and FDA design control requirements (21 CFR 820.30) as applied to medical device software and medical device regulations including ISO 13485, ISO 14971, and IEC 62304.
• A strong track record of software testing, computer software validation and quality assurance.
• Success creating and implementing systems engineering standard operating procedures (SOPs): exploratory prototyping phases; integrated risk management; Human Factor/Usability Engineering; cybersecurity and medical device development lifecycle.
• Experience with at least one of the following programming languages: Java (Spring), TypeScript, Python, Scala, Go.
• Technical leadership through coordinating teams of Developers, Testers and Architects across the software development lifecycle./li>
• Initially, you’ll need to be comfortable with working 100% remotely. In time, we anticipate you’ll spend 3-4 days a week in the office and 1-2 days working from home.

About the business

You’ll be part of a global top-20 pharma business with a research-driven focus on innovative therapies that can extend patients’ lives and improve animal health. Importantly, the company is family-owned so people are free to focus on sustainable goals, not short-term shareholder returns. All in all, it’s a positive, progressive place to work – the ideal setting to develop your career.

Nowhere is this more apparent than in the company’s digital incubator, where leaders are encouraged to explore how digital innovations can be leveraged to accelerate the development of better healthcare for humans and animals.

Find out more

Start something new. To find out more about the role, the rewards and the business click the enquire today button.