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.

As MindMaze’s Product Quality Engineer you will join our Quality Assurance and Regulatory Affairs team. You will be responsible for assuring new or modified Medical Devices reliably meet customer requirements and needs. To achieve this, you will promote and nurture the highest standards of professionalism, ethics, and compliance, and actively support our compliance program-related initiatives.

Product Quality Engineer is an interface between Quality Assurance, Engineering and Manufacturing sub-contractors to facilitate organizational success by protecting 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:

• Interact with development engineers to design transfer to manufacturing, especially on the Device Master Record documentation to ensure completeness, accuracy, and testability of product requirements
• Provide support to engineering in any quality issues with tooling, machines or processes, and evaluates and recommend inspection gauges, test equipment and inspection methods
• Be accountable to define and execute manufacturing processes validation activities required for MindMaze device portfolio
• Lead manufacturing processes qualification by ensuring all FDA and ISO requirements are met and for the review and approval of all protocols and reports (VMP, IQ, OQ, PQ)
• Perform or ensure FMEAs for processes and products under development and/or qualification
• Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line
• Inspect and release production material, components, and finished products
• Participate in the vendor survey activities as applicable
• Drive proactive participation with suppliers involved in Design Transfer and, when possible, aids in their process validation efforts
• Review all supplier discrepancies and deviation request, coordinate and track the effectiveness of action plans
• Perform detailed Root Cause Investigation of failed products (components, materials, sub-assemblies and finished goods) or processes using various quality tools and manage the disposal of non-conforming material when required
• Evaluate all post launch purposed design changes to determine impact on risk level, verification and/or validation testing as part of the Change Control process
• Uses post-production and post-market analytics and statistics to report on product quality performance in the field (provide feedback to suppliers or design teams) and ensure adequate corrective/preventive actions are effective to eliminate/mitigate the issue

To support you, MindMaze will:

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

Skills that we look out for are among

• Minimum Master’s degree in Engineering discipline preferably in mechanical, electrical, or manufacturing engineering
• +3 years Product Quality experience in healthcare and/or highly regulated industry
• Experience in a FDA regulated industry and ISO 13485 certified organization
• Hands on experience in medical device manufacturing process risk analysis
• Experience with supplier management, component qualification practices and transferring production lines
• Proficient with utilization of quality tools (Six Sigma, Lean Manufacturing, 5S, SPC, Sampling Principles, Root Cause Analysis, PFMEA, DOE, Gauge R&R, etc.)
• Fundamental understanding of electronic and electromechanical designs and manufacturing processes to support designing, troubleshooting, refining and qualifying the design to ensure the sustainable manufacturing of medical devices
• 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
• Willingness to travel all over the world to support the company growth (on a non-recurring basis, more at a sporadic frequency – travels of few days and up to 2 weeks)

Icing on the cake

• Contributing to the development of Control Plans, Design of Experiments, Measurement Systems Analyses, and Process Capability Analyses
• Experience statistical analysis tools
• Prior exposure to a Holacratic organization and/or Agile development framework

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.