Senior Manager, Manufacturing Operations (Medical Device)

Job description

**What is Motif?** Motif is a medical device startup based in Houston, Texas. We are designing and developing minimally invasive electronic solutions for serious mental health conditions. Powered by our patent-pending methods for wireless power and data transmission, our goal is to create the smallest implantable brain stimulator to treat people with mental health disorders. We are an early-stage startup with funding from venture capital firms, grants, and private angel and founder investments. Motif’s technology stack consists of a small implant that is wirelessly powered via magnetic fields from an external wearable transmitter, configured and controlled from a programming interface. It delivers novel stimulation therapy to cortical targets and will evolve to record biomarkers of symptoms, disease state, and therapy response. **Where are we going?** We are currently completing the development of our first minimally invasive neural stimulation system and preparing for future versions with additional functionality based on our platform technology. **About the Job** We are seeking candidates with a background in medical device manufacturing and operations (supply chain, purchasing, inventory management)to ensure that we have everything we need to build high quality medical devices on time. If you have a passion for building innovative medical technologies and helping others do the same, apply now to be part of our dedicated team. You will manage our manufacturing function by selecting and implementing our inventory and manufacturing management software, working with engineering to write and refine our manufacturing processes, and managing a supply chain and multi-lab facility to build Class III innovative neural implant devices. This role will manage a small team of operators and operations team members to execute manufacturing and operations work. This job is an ideal role for somebody well-versed in medical device manufacturing who wants to grow into broader operations management such as inventory, facilities, supply chain, and purchasing. Job Location: Onsite in Houston, Texas. **Does this sound like you?** - Do you like creating systems and processes to help others do great work? - Do you believe that openness and honesty are key to team success? - Do you want to create a future where technology enables better mental healthcare? If yes to the above, then you may love working with Motif as it is being built by highly dedicated people with passion for neurotechnology, clinical product development, and putting the patient first. We are looking for people with the same energy who will thrive in a high growth, high autonomy environment. **In this role, you will:** - Establish and refine processes to support high quality medical devices - Continuously improve processes for handling equipment, calibration, maintenance, inventory management, and manufacturing records - Work closely with engineering to validate and implement new processes or help refine existing processes for manufacturing - Partner with engineering to identify and evaluate new potential processes - 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 - Participate in the Change Control Board (CCB) as the operations representative, reviewing proposed design, process, and material changes for manufacturing and inventory impact - Onboard and manage software, tooling, and new manufacturing equipment and processes to support resource planning, part lifecycle management, and new manufacturing procedures - Manage the team that manages supply chain by selecting suppliers, working with quality on effective supplier agreements, and monitoring supplier performance - 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/operations in weekly meetings and in a quality documentation reviews - Manage and maintain the facility and team - Ensure facilities are operational and safe by implementing and following OSHA guidelines and establishing and maintaining PPE requirements, safety markings, and more - Oversee a 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 (a few times per year at most) - This is not an exhaustive list of duties and you may be asked to perform different tasks if your role within or the objectives of the organization changes. **To be considered, you will need:** - 8+ years of experience in manufacturing - 3+ years of experience in medical device manufacturing and cGMP manufacturing - 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 - To be available to work onsite full-time in our Houston, Texas office (relocation assistance available) **It is a bonus if you have:** - Experience managing or implementing a BSL Level II or stricter lab - Experience with in-house sterilization and packaging - 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 **Work Authorization Notice** Motif Neurotech hires only individuals who are authorized to work in the United States. At this time, visa sponsorship is not offered for this role. **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 We envision a world where everyone with a mental health disorder can get well and stay well, regardless of who you are, where you live, or how much money you make, and we are excited to build that future with you. Let’s use our powers for good. Motif Neurotech is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other protected class status. \*for regular full-time, exempt, salaried US employees