Design Quality Engineer
mindmaze
Lausanne, Switzerland
vor 4 Tg.

Company Description

MindMaze is the world’s leading Neurotechnology start-up built on more than a decade of pioneering research at the intersection of virtual reality and neuroscience.

Our breakthrough platform combines virtual & augmented reality, neuroscience and artificial intelligence to build intuitive human machine interfaces.

Our first products help patients suffering from severe disabilities following a neurological incident.

Join our eclectic mix of scientists, physicists, engineers and clinicians, and grow with MindMaze.

Job Description

As MindMaze’s Design Quality Engineer, you will join our Quality Assurance and Regulatory Affairs team. You will be responsible for assuring new or modified 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.

Design Quality Engineer is an interface between marketing, engineering, quality, and process design 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 :

  • Support medical device entire lifecycle from product concept to Product launch, 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,
  • Develop and carry out tests to gauge the safety levels of products and work third-party test labs during device safety certifications.
  • To support you, MindMaze will :

  • Provide an international collaborative work environment
  • Provide mentoring
  • Allow flexible employment terms and conditions
  • Qualifications

    Skills that we look out for are among

  • Minimum Master’s degree (in Engineering discipline) preferably in mechanical, electrical, software, biomedical or equivalent experience,
  • 2 to 5 years Design Quality experience in the medical device industry,
  • Experience in an FDA regulated industry and ISO 13485 certified organization,
  • Strong knowledge of medical device regulations and the associated relevant standards applicable to medical devices, including Risk Management, Usability, Electrical safety, Medical Software Validation, Biocompatibility, and Clinical Evidence.
  • 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 (level C1) with minimum B2 level in French.
  • Icing on the cake

  • Contributing to the Medical Device Software Validation,
  • Knowledge of Clinical evidence requirements (literature review, clinical trials, PMCF ),
  • Participating to Usability studies,
  • Prior exposure to a Holacratic organization and / or Agile development framework.
  • Additional Information

    To be successful, you can illustrate the fact that you have the following abilities :

  • Service orientation with recognized mentoring skills and an ability to adapt communication style to a wide variety of audiences;
  • Ability to build constructive work relationships and at ease with interacting with colleagues at all hierarchical levels;
  • Extremely well organized, with a strong focus on detail, and the ability to set levels of detail-orientation that you require colleagues to meet;
  • Ability to demonstrate initiative and to solve problems in a fast-paced, ever-changing business environment. Displaying a high level of critical thinking in bringing successful resolution to high impact, complex, and / or cross-functional problems;
  • Ability to work with minimal supervision and to make decisions even if provided with limited information;
  • A good sense of humor and at ease working both autonomously and as being part of a team.
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