Sr. SaMD RA/QA Engineer

Quality & regulatory       ·       Lausanne, Switzerland       ·       Full time

Company Description

Founded in 2012, MindMaze is a global leader in brain technology and digital neurotherapeutics solutions for brain health and recovery. Its mission is to accelerate the brain’s ability to recover, learn and adapt. The company has two core divisions – Healthcare and Labs – working collaboratively at the intersection of neuroscience, bio-sensing, engineering, mixed reality and artificial intelligence. 

MindMaze Healthcare is advancing a universal platform for brain health with breakthrough solutions to some of the world’s most challenging problems in neurology, including stroke, Parkinson’s disease and Alzheimer’s disease. MindMaze Labs, the company’s R&D innovation hub, is focused on the future of human computing – working across multiple industries to innovate and build the next generation of human-machine interfaces. The company has offices in Lausanne, Baltimore, London, Paris and Mumbai. 

Job Description

You will join our Quality Assurance and Regulatory Affairs team. You will be responsible for assuring new or modified Software as Medical Devices conform to quality standards and establish compliance with the quality system. To achieve this, you will contribute to the streamlining and continuous improvement of the product development process and ensure robust, and efficient development and launch of new and innovative products.

You will be the interface between marketing, software developers, software testers, and project manager to facilitate organizational success by ensuring patient/user safety and meeting business needs.

Being part of a small team in a scale-up environment such as MindMaze implies that you will be given the opportunity to share your experience to support company growth.

You will:

• Manage all Quality Assurance activities related to software development according to IEC62304,
• Provide guidance to engineers on regulatory compliance for Software, Cybersecurity, Artificial Intelligence and any Data Protection Regulations,
• Support Software as Medical Device entire lifecycle from product concept to PMS and registration handling, including for instance DHF and EC Technical file completion,
• Act as team member representing Quality Assurance and Regulatory Affairs into New Product Development and sustaining engineering projects and ensure on-time completion of Design Control Deliverables,
• Be part of Design Verification and Validation activities,
• Lead device Risk Management activities from product concept through commercialization,
• Apply internal development procedures to the product development teams, within the framework of regulatory requirements,
• Be responsible for co-leading gate reviews and reviewer on all NPD document approvals,
• Interact and sustain constructive working relationships within project team members to ensure cross-functional customer needs are met without creating barriers to development cost, schedule and performance,
• Ensure compliance of device accompanying documents and related marketing materials,
• Evaluate RA impacts related to events registered into the corporate processes like CAPA, Customer Complaint, Deviation or Design Change.

Qualifications

Skills that we look out for are among

• Minimum Bachelor’s degree in Engineering/Software, or Engineering/Computer Science
• 5+ years experience in Regulatory Affairs Software in the Medical Device industry
• Good experience in an FDA regulated industry and ISO 13485 certified organization
• Strong knowledge of software as medical device regulations and the associated relevant standards applicable to minimum class-B software,
• Advanced personal computing skills and familiarity with a variety of business software packages including Office, Atlassian tools, ERP and able to learn new technologies quickly
• Fluent in English (C1) French would be nice to have 

Icing on the cake

• Contributing to the V&V of Software as Medical Device,
• Participating to Usability studies,
• Prior exposure to a Holacratic organization and/or Agile development framework

Additional Information

What we offer:

• A scale-up company in innovative therapies
• Dynamic and driven team
• Flat hierarchies
• Flexible work environment
• Excellent location, easily accessible with an amazing lake view
• A workplace that supports diversity, inclusion and parenthood
• Unlimited coffee, fresh fruits and snacks  

Please click here to apply.