Design Assurance Engineer

Team Description:

We are creating the future of brain-computer interfaces: building devices now that have the potential to help people with paralysis regain mobility and independence, and inventing new technologies that could expand our abilities, our community, and our world.

From day one, you will be boots-on-the-ground with engineers in support of our products. You will execute and improve design control activities and work with multiple engineering teams (Surgery, Implant, Robot), learning the existing frameworks and developing a process that’s sustainable and scalable. The ideal candidate is someone with an engineering mindset with strong design controls and risk management skills, with the ability to parse important details from ambiguity, and who is comfortable collaborating with product development engineers and manufacturing engineers. You will help the nascent products in the pipeline efficiently complete medical-grade design and manufacturing processes and, by doing so, ensure the highest standard of product reliability and performance.

Job Responsibilities and Description:

• Ensure that compliance with customer requirements, risk management, quality, and design control standards is demonstrated throughout design and development projects, with a particular emphasis on Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) applications.
• Facilitate the successful transfer of designs to manufacturing, ensuring that software components meet medical device regulatory standards.
• Participate in decisions regarding the scope of work, selection of materials, equipment, test methodologies, design reviews, and design changes, specifically focusing on software elements within medical devices.
• Collaborate with cross-functional teams to develop, apply, revise, and maintain quality and regulatory standards for designing and processing materials and products into partially or finished medical device products, including software components.
• Implement methods by working alongside engineers to inspect, test, and evaluate the precision and accuracy of software and/or production equipment.
• Diagnose and resolve manufacturing and quality system issues related to software components in medical devices.
• Participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new software processes.
• Generate and maintain risk management files supporting product development, including Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices, Post Market Surveillance plans, and other related documents, with a focus on software-related risks.
• Provide guidance and generate reports on topics involving statistical analysis, including sample size requirements, process capability analysis, regression analysis, tolerance interval analysis, and ANOVA, as they pertain to software testing and validation.
• Support Product/Process Development Engineering in optimization activities by guiding Design of Experiments of various process parameters and analyzing data related to software performance.
• Follows all safety and production standard operating procedures
• Use first principles when designing a process ensuring it’s not cumbersome for non QS members, and can support rapid iterations.
• Defining problems as much as solving them.
• Know that what matters is delivering a solution that works every time and is efficient for engineers.
• Work collaboratively with cross-disciplinary team members, including software, mechanical, electrical, materials, biological engineers, and neuroscientists, to integrate software solutions seamlessly into medical devices.
• Resourceful, flexible and adaptable; no task is too big or too small.

Required Qualifications:

• Bachelor’s Degree in science or engineering, or equivalent in experience and ability.
• Experience with medical device best practices and regulatory requirements for FDA and/or international bodies, specifically concerning SaMD and SiMD.
• Strong understanding of engineering first principles as they apply to software development.
• Experience with SaMD/SiMD quality systems, risk management, and compliance.
• Excellent verbal and written communication.
• Relentless attention to quality.
• Experience building processes that are scalable.

Preferred Qualifications:

• 2+ years of experience with rigorous design control processes in the medical device industry, particularly related to software development.
• 1+ years of experience working in risk management, with a focus on software-related risks in medical devices.