Director of Manufacturing Operations (Medical Device)

Motif Neurotech • Houston, TX

7d • Onsite

About The Position

Motif is a medical device startup based in Houston, Texas, focused on developing minimally invasive electronic solutions for serious mental health conditions. We are seeking candidates with a background in medical device manufacturing, process design and improvement, and supply chain management to ensure the production of high-quality medical devices on time. This role will manage the manufacturing function, including selecting and implementing inventory and manufacturing management software, writing manufacturing processes, and managing a global supply chain and multi-lab facility for Class III innovative neural implant devices. The position involves close collaboration with design engineering to develop new processes and bring new manufacturing technologies online, as well as managing a small team. This is an ideal role for someone experienced in medical device development, manufacturing, and process improvement who wishes to expand into broader operations management, including inventory, facilities, supply chain, and purchasing.

Requirements

• 6+ years of experience in medical device manufacturing and cGMP manufacturing
• 1+ years of experience in a finance/operations role or a manufacturing role with budget and expense responsibilities
• 2+ years of experience hiring and managing performance for teams of manufacturing engineers, technicians, and/or support staff
• Substantial experience working with manufacturing resource planning or enterprise resource planning software for the purpose of managing manufacturing operations and builds (work orders, sales orders, etc)
• Experience in manufacturing and design documentation development, including writing and improving manufacturing procedures, developing or identifying areas for in-process inspections and influencing design for manufacturability
• Some experience in purchasing, procurement or supply chain management
• Demonstrable strong written and verbal communication skills for cross-departmental coordination
• Experience working under a Quality Management system (ISO 13485/21 CFR Part 820), and working with both design files and manufacturing records
• Experience developing new processes or bringing online new process technologies
• To be available to work onsite full-time in our Houston, Texas office (relocation assistance available)

Nice To Haves

• Experience managing or implementing a BSL Class II or stricter lab
• Experience with in-house sterilization and packaging
• Experience with laser cutting and welding technologies
• Experience owning process validation (IQ/OQ/PQ) and FMEA/risk management activities for regulated products
• Experience in managing or implementing an ISO 7 or stricter cleanroom manufacturing environment

Responsibilities

• Design and establish processes to support quality products
• Develop and improve manufacturing processes for handling equipment, calibration, maintenance, inventory management, and manufacturing records
• Write manufacturing work instructions alongside engineering to help ensure products are designed for manufacturability
• Work with quality and engineering to conduct risk assessments (pFMEAs), monitor build quality, and inspected at appropriate control points
• Own the process validation strategy across the product lifecycle, including IQ/OQ/PQ planning, protocol authorship, execution, and summary reporting
• Lead manufacturing readiness reviews prior to design transfer and participate in the Change Control Board (CCB) as the manufacturing representative, reviewing proposed design, process, and material changes for manufacturing impact
• Onboard and manage software, tooling, and new manufacturing equipment and processes to support resource planning, part lifecycle management, and new manufacturing procedures
• Run manufacturing and inventory operations
• Manage inventory and ensure full product and part traceability through receiving, inspection, and marking and labeling procedures
• Develop the build schedule and ensure builds are prioritized and changes are communicated to appropriate stakeholders
• Purchase supplies, tooling, and capital equipment for engineering and manufacturing according to our purchasing procedures
• Represent manufacturing in weekly meetings and in a quality documentation capacity
• Manage and maintain the facility and team
• Manage supply chain by selecting suppliers, working with quality on effective supplier agreements, and monitoring supplier performance
• Ensure facilities are operational and safe by implementing and following OSHA guidelines and establishing and maintaining PPE requirements, safety markings, and more
• Oversee a growing team of manufacturing engineers, technicians, and operations/supply chain personnel, including hiring, onboarding, and performance management, and set work direction across the function
• Own the environmental controls and monitoring program for controlled manufacturing areas (e.g., cleanroom classification, particulate monitoring, gowning procedures) required for Class III device production
• Ensure manufacturing's adherence to the company's Quality Management System, including DHF/DMR contributions, CAPA participation, and audit readiness
• Occasionally travel to supplier conferences/trade shows such as MD&M West and/or to visit contract manufacturers and suppliers in Taiwan

Benefits

• Medical, dental, and vision insurance for you and your dependents
• Participation in our 401k plan
• Unlimited PTO
• The chance to work with an incredible group of people working towards a common goal for a better future

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed