Sr. SaMD RA/QA Engineer (Hybrid)

Raleigh, NC       ·       Full time

About MindMaze

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 and has operations in more than 20 countries. For more information, please visit www.mindmaze.com.

Job Description

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, FDA product registration under 510(k) or De Novo minimum and EC Technical file completion to comply with MDR.
• 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

• Minimum Bachelor’s degree in Engineering/Software, or Engineering/Computer Science 
• 5+ years experience in Software as Medical Device industry
• Good experience in an FDA regulated industry and/or 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

Additional Information

Benefits

• Health insurance
• Paid time off
• Dental insurance
• 401(k)
• Vision insurance
• Flexible schedule
• Tuition reimbursement
• Life insurance
• 401(k) matching
• Referral program
• Employee discount
• Flexible spending account
• Health savings account
• Relocation assistance
• Parental leave
• Professional development assistance
• Employee assistance program
• Other

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

• While performing the duties of this position, prolonged periods of sitting at a desk and working on a computer may be required.
• Additionally, the employee is regularly required to talk or hear.
• The employee frequently is required to use hands or fingers, handle, or feel objects, tools, or controls.
• The employee is occasionally required to stand; walk; sit; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl.
• The employee must occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus.
• The noise level in the work environment is usually moderate.
• Ability to travel on a flexible schedule.

Mindmaze provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Please click here to apply.