Director of Manufacturing Operations - Medical Device

About Motif Neurotech

Motif Neurotech is an innovative medical device startup situated in Houston, Texas, focused on developing minimally invasive electronic treatments for severe mental health issues. Leveraging our unique patented wireless power and data transmission technology, we aim to produce the smallest implantable brain stimulator designed to improve mental healthcare outcomes. Supported by venture capital, grants, and private funding, our platform consists of a small implant wirelessly powered via magnetic fields from an external wearable transmitter, configurable through a programming interface. Our technology delivers new stimulation therapies targeting the cortex and plans to evolve to capture biomarkers related to symptoms, disease status, and therapy responses.

Job Overview

We are completing development of our initial neural stimulation system and planning advanced versions with expanded capabilities. We seek a professional with expertise in medical device manufacturing, processes, and supply chain management. This leadership role involves overseeing manufacturing functions including selecting and implementing inventory and production management software, documenting manufacturing processes, managing global supply chains and facilities to produce Class III neural implant devices at clinical quality standards, and collaborating closely with design engineering to develop and implement new manufacturing technologies. You will manage a small team executing manufacturing operations and play a pivotal role in scaling operations and process improvements.

Key Responsibilities

• Design and implement manufacturing processes that ensure high-quality product delivery.
• Enhance procedures related to equipment handling, calibration, maintenance, inventory, and record keeping.
• Create manufacturing work instructions in collaboration with engineering to improve product manufacturability.
• Collaborate with quality and engineering teams on risk assessments, quality monitoring, and inspections.
• Develop and lead process validation strategies through lifecycle phases including IQ/OQ/PQ activities and reporting.
• Lead manufacturing readiness evaluations prior to design transfers and participate as manufacturing representative in change control decisions.
• Manage onboarding and maintenance of manufacturing software, tooling, equipment, and procedures.
• Oversee daily manufacturing and inventory operations ensuring full traceability and proper labeling.
• Develop production build schedules, prioritize builds, and communicate changes to stakeholders.
• Handle procurement of supplies, tooling, and capital equipment per company purchasing policies.
• Represent manufacturing in meetings and maintain quality documentation standards.
• Manage facility operations, ensure safety compliance, and uphold OSHA guidelines including PPE and safety markings.
• Lead and expand a team of manufacturing engineers, technicians, and supply chain staff, including hiring and performance oversight.
• Administer environmental controls and monitoring for controlled manufacturing spaces (e.g., cleanrooms, gowning, particulate monitoring).
• Ensure compliance with the Quality Management System, contribute to design history files, device master records, CAPA processes, and audit readiness.
• Occasional travel to industry events or supplier sites, including visits to contract manufacturers and trade shows.

Qualifications

• At least six years of experience in medical device and cGMP manufacturing.
• One or more years in finance, operations, or a manufacturing role with responsibility for budgets and expenses.
• Minimum two years managing teams of manufacturing engineers, technicians, or support staff.
• Proficiency with manufacturing resource planning or enterprise resource planning software to manage production workflows.
• Experience creating and improving manufacturing and design documentation, enforcing design for manufacturability and inspection protocols.
• Familiarity with purchasing, procurement, and supply chain management functions.
• Strong verbal and written communication skills supporting cross-functional collaboration.
• Experience operating within Quality Management Systems such as ISO 13485 and 21 CFR Part 820, managing manufacturing and design records.
• Proven success introducing and managing new manufacturing processes and technologies.
• Immediate availability to work onsite in Houston, Texas; relocation assistance is provided.

Preferred Experience

• Management or implementation experience in BSL Class II or higher labs.
• Knowledge of sterilization, packaging, laser cutting, and welding technologies.
• Hands-on process validation including IQ/OQ/PQ and risk management (FMEA) for regulated medical products.
• Experience operating or setting up ISO 7 or stricter cleanroom manufacturing environments.

Additional Information

Motif Neurotech only employs individuals authorized to work in the USA; visa sponsorship is not available for this position. We offer medical, dental, and vision insurance for employees and dependents, a 401(k) retirement plan, unlimited paid time off, and the opportunity to collaborate with a passionate team dedicated to advancing neurotechnology and patient-centered clinical product development.

We envision a future where everyone affected by mental health disorders can access effective treatment regardless of their background or circumstances. Join us in our mission to improve lives with cutting-edge technology.

Motif Neurotech is committed to equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or other protected categories.