Software Design Compliance Engineer

  • MindMaze
  • https://jobs.smartrecruiters.com/MindMaze/743999777344878-software-design-compliance-engineer
  • 13/10/2021
Full time Data Science Data Engineering Data Analytics Big Data Data Management Statistics

Job 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.

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.
Senior Software Design Compliance Engineer is an 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
  • 7+ years experience in Software as 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 or French (C1) with Minimum B2 level in the other language

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

  • Working autonomously: setting tasks and direction under limited supervision
  • Oral and written communication: ability to write clearly and succinctly in a variety of communication settings and styles; ability to get messages across that have the desired effect
  • Planning accurately: setting objectives and goals; breaking down work into the process steps; developing schedules and task/people assignments; anticipating and adjusting to problems and roadblocks

MindMaze will:

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