Manufacturing Manager

Spectral MD Inc•Dallas, TX

4d•Onsite

About The Position

Spectral AI is seeking an experienced team-oriented Manufacturing Manager to lead Manufacturing and Procurement operations of our medical products. The position will report to the General Manager and will collaborate with contract manufacturers, suppliers, and internal cross functional teams to ensure the efficient production of safe products that meet customer requirements.

Requirements

Bachelor’s or Graduate Degree in Engineering, Operations Management or related field or equivalent experience.
5 years of FDA/ISO 13485 regulated Medical Device Manufacturing and Supply Chain industry experience supporting production of FDA Class II or III medical products.
Process Validation
Deep understanding of FDA/ISO13485 QMSR requirements with direct experience representing Manufacturing/Supply Chain operations in periodic surveillance audits.
Demonstrated experience with managing contract manufacturing of medical products.
Experience working in a multidisciplinary environment producing complex high quality medical products.
Effective communicator with a successful track record of mentoring and building effective teams.
Position requires a hands on approach. Must be willing to pitch in during peak activity to ensure team objectives and timelines are met.

Nice To Haves

Experience with UL/MET Electrical Safety compliance inspections and ability to support Contract Manufacturer to maintain compliance.
Lean 6 Sigma Green Belt certification or higher.
Experience utilizing NetSuite ERP, and Greenlight Guru EQMS Systems preferred.
Excellent verbal and written communication skills

Responsibilities

Provide overall leadership to the Manufacturing Engineering and Procurement teams.
Establish operational goals/strategies and related departmental performance KPI’s.
Responsible for Regulatory compliance and representing Manufacturing and Procurement operations in periodic ISO 13485, FDA, and State of Texas compliance inspections.
Responsible for manufacturing process development, process risk management and process validation activities.
Manages successful design transfer of new products to contract manufacturers.
Lead Sales and Operations planning meetings to ensure on time delivery of high quality, safe products that meet customer requirements.
Develop department budgets and manage expenses and capital needs within budget guidelines.
Coordinate timely investigations, root cause analysis and implementation of corrective/preventative actions to address CAPA’s and nonconformances related to Manufacturing/Procurement.
Support internal cross functional teams related to New Product Development, Sustaining Engineering, Quality Improvement and other projects as assigned by Senior Leadership.
Build a highly skilled, highly regarded and motivated customer focused team that mentors individual members to achieve their full potential.
Develop improvement strategies based on the business goals and aligned with Lean Manufacturing principles in compliance with applicable agency regulations.