Design Quality Engineer
Empatica, Italy

Empatica is a full-stack digital healthcare company and a pioneer in digital biomarker development and continuous patient monitoring driven by AI. Our platform consists of medical-grade smartwatches, software, and physiological and behavioural digital biomarkers. Together they enable the continuous remote monitoring of human health across a range of conditions, through clinical-quality digital measurements.

If you are looking to join a fast-paced growth environment and do meaningful work that can make a true impact in the world, then keep reading.

As a Design Quality Engineer at Empatica, you will be a key member of the Quality and Regulatory Department, supporting the maintenance of design control documentation as well as:

• Champion Quality culture and compliance within the different development teams, supporting them in the compliance effort
• Continually seeks to drive improvements in product and process quality
• Provides the quality/independent review at defined design reviews, design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing products
• Support team in performing required Risk Management activities
• Support the Engineering manager with activities related to change management and new product development. Support developers in creating design control documentation, making sure product requirements and regulatory requirements are aligned
• Support Design transfer activities to ensure quality compliance of the manufacturing process
• Interface with Regulatory Affairs, Clinical Science, Marketing, and product manager to translate their needs into actionable and regulatory-compliant requirements
• Implement, maintain, and update procedures that ensure that the design control process constantly meets Empatica’s and regulatory requirements
• Support Regulatory affairs in drafting EU Technical Documentation and US 510(k)s and De Novo submissions
• Keep up to date on all ISO/EN/FDA/MDR and other Product Development related regulatory requirements and relay this information to the Product Development group

Important detail:

• Empatica is an international environment with offices in Europe and the US, and so we conduct all our work in English

Requirements

The ideal candidate for this role:

• Has a genuine interest, passion, and motivation for Empatica's mission
• Has a strong academic background, BS or MS in Biomedical Engineering
• Has at least 3 years of experience as a Design Quality Engineer, Quality Engineer, or similar roles in a company that designs/manufactures medical devices
• Has knowledge and experience working with ISO standards (13485, 14971, ...)
• Has knowledge and experience working with IEC standards (60601, 62304, ...)
• Has knowledge of MDR 2017/745
• Has excellent analytical and problem-solving skills
• Is an autonomous person, with good organization and management skills
• Is a native English speaker or has worked in English for the past at least 3 years

You will join a fast-growing, international, and diverse team of 120+ talented people who care passionately about what we do and the difference we are making in the world. You’ll get the opportunity to work directly with colleagues across all levels of the organization, no matter their seniority, and learn from the people that built the business and our products.

If you jump on board, we can guarantee it won't be an easy ride, but it will be one of the most rewarding experiences in your career, one that will allow you to learn a lot, have true ownership of your work, and test your whole skillset on multiple projects which are helping thousands of people worldwide.

Read our blog post and find out some reasons why we love working at Empatica.

At Empatica we embrace diversity and inclusion. We have colleagues from 30 different countries, while over 50% of our team is women (double the tech average!). We believe this makes Empatica a more exciting and stimulating place to work, and brings different points of view to the table while fostering a spirit of communication, collaboration, and care, where everyone’s opinion and thoughts matter

Benefits

• Multiple opportunities to be challenged and step up your career in a fast-growth company in one of the hottest areas of tech
• Competitive salary
• Employee stock options - we want everyone who joins us to own part of the company and our success
• We have offices in Milan City Center and Downtown Boston. And every summer, we hold an amazing beach retreat in Sardinia, Italy
• Health Insurance
• Gympass

Job Rewards and Benefits