Restorative Neurotechnologies

QA Engineer

• Participate in ongoing implementation of the Quality Management System (QMS) in conformance with US FDA QMSR, ISO 13485, IEC 62304, and IEC 62366-1 and other relevant standards.
• Support the product development team in creation of design history files (DHFs) including product requirements, software architecture and design specifications, design verification and validation test protocols and reports, risk management file, cybersecurity documentation, traceability matrices, etc.
• Guide and lead risk management activities, including failure modes and effects analysis (FMEA) and hazards analysis, in alignment with ISO 14971.
• Guide and lead computerized system assurance and validation activities for SW tools and systems.
• Engage and collaborate with suppliers and support design, development and design transfer activities.
• Support and participate in internal and external audits, coordinating and providing documentation and evidence of compliance.
• Support root cause analysis for nonconformances, defects and CAPAs, issue management, management review and quality data analysis.
• Foster a collaborative environment, champion continuous improvement initiatives and promote a quality culture across the organization.

Senior Software Quality Engineer

Mechanical Engineer

• Work alongside software engineers to author, review, and maintain comprehensive design control documentation, including Software Requirements Specifications, Architecture & Design Documents, and Traceability Matrices.
• Ensure software development processes align with IEC 62304 (Medical Device Software Lifecycle), ISO 13485, and FDA 21 CFR Part 820 regulations.
• Author and maintain software risk management files, including Software FMEAs per ISO 14971.
• Produce software verification and validation (V&V) protocols and reports in coordination with the engineering and test teams to ensure full traceability.
• Compile and organize necessary software technical documentation for regulatory submissions.
• Maintain and update software documentation for post-market surveillance, CAPAs, and software updates.

Software Design Control Engineer

Security Engineer

• Lead security architecture, implementation, and maintenance of our cloud-based data platform, applications and medical devices.
• Establish security review processes for all new products and features.
• Guide security features through the complete product lifecycle.
• Prototype security requirements and educate the broader engineering team on secure coding best practices.
• Work cross-functionally with internal software, hardware, quality, and regulatory teams.

General

• Serve as the Senior Histopathology Technician for a variety of biocompatibility, safety, and efficacy studies for medical devices and associated products in accordance with GLP for Nonclinical Laboratory Studies (Title 21, Part 58).
• Prepare tissue samples for Pathologist macroscopic and microscopic examinations using various techniques such as fixation, embedding, sectioning, staining, mounting, and imaging.
• Operate and maintain laboratory equipment, including microtomes, tissue processors, staining stations, and cold storage. Work closely with Quality Assurance (QA) to develop and conduct quality control checks to ensure the precision and reliability of laboratory tests and outcomes.
• Strictly adhere to laboratory protocols and safety procedures to prevent contamination and ensure the accuracy of test results.
• Manage laboratory supplies by maintaining inventory and working with the Lab Manager and Procurement to order necessary materials, as needed.
• Work proactively with Study Director to ensure that any protocol changes related to the processing of tissues are approved and documented in accordance with GLP practices.
• Work collaboratively with department management, CROs, and Quality Assurance (QA) to exceed Sponsor expectations in the conduct of studies.
• Ensure that unanticipated responses of study data are corrected, accurately recorded, and verified by working directly with the Study Director to maintain documentation of corrective actions in accordance with regulatory guidelines.
• Review raw data for technical content and regulatory compliance.
• Contribute to and prepare GLP study reporting for submission to relevant regulatory agencies to support the company’s applications for clinical use.
• Participate in continuing education to stay current with the latest techniques and advancements in histopathology.

Senior Histopathology Technician

• Perform soldering and rework on PCBs, including 0201 discretes and fine-pitch BGAs under a microscope
• Execute board modifications, debug issues, and support rapid design iterations
• Follow detailed work instructions, schematics, and test procedures with high accuracy
• Run functional tests on incoming and assembled hardware; document results clearly
• Support incoming inspection and ensure hardware meets quality standards
• Assist with lab operations, including organization, equipment upkeep, and basic lab management
• Calibrate and maintain test equipment; coordinate with external vendors as needed
• Partner closely with engineers to troubleshoot issues and improve designs

Senior Electronics Technician

• Serve as the Anatomic Pathology Technician for a variety of biocompatibility, safety, and efficacy studies for medical devices and associated products in accordance with GLP for Nonclinical Laboratory Studies (Title 21, Part 58).
• Perform necropsies, conduct gross examinations, and document descriptions of tissue specimens. Prepare and dissect tissue samples for Pathologist microscopic examinations.
• Operate and maintain laboratory equipment, including microtomes, tissue processors, staining stations, and cold storage.
• Strictly adhere to laboratory protocols and safety procedures to prevent contamination and ensure the accuracy of test results.
• Work proactively with the Senior Histopathology Technician to ensure that any protocol changes related to the processing of tissues are approved and documented in accordance with GLP practices.
• Work collaboratively with department management and Quality Assurance (QA) to exceed Sponsor expectations in the conduct of studies.
• Ensure that unanticipated responses of study data are corrected, accurately recorded, and verified by working directly with the Study Director to maintain documentation of corrective actions in accordance with regulatory guidelines.
• Contribute to GLP study reporting for submission to relevant regulatory agencies to support the company’s applications for clinical use.
• Participate in continuing education to stay current with the latest techniques and advancements in histopathology.

Anatomic Pathology Technician

SDET

• Define and design end-of-line and in-process manufacturing test systems to validate core product functionality
• Translate system and product requirements into comprehensive test plans, specifications, and coverage
• Design and develop test fixtures and hardware, including PCB-level interfaces and basic mechanical structures (how devices are held, connected, and tested)
• Develop test software using tools like LabVIEW or Python to automate test execution and data collection
• Collaborate with EE, ME, firmware, and systems teams to ensure testability is built into the product design
• Lead bring-up, validation, and optimization of manufacturing test systems
• Analyze test data, debug failures, and drive root cause investigations
• Support scaling from prototype builds to production, improving test efficiency, reliability, and throughput
• Work with contract manufacturers and vendors to deploy and maintain test systems

Senior Systems Test Engineer – Manufacturing Test

Engineering Manager

• Introduce and foster engineering best practices that emphasize code quality, modularity, usability, and long-term flexibility.
• Mentor and develop engineers through regular feedback, coaching, and technical guidance, including people-management responsibilities.
• Contribute to the design and implementation of key modules across desktop & mobile apps for multiple products.
• Partner closely with Quality and Regulatory teams to produce high-quality technical documentation.
• Translate validated research concepts into robust, production-quality software.