Would you like to manage the manufacturing of complex disposable medical devices that fix broken hearts?
You could do that every day in this hands-on managerial role, reporting to the VP of Operations at a growing Class 3 medical device company. The focus of this challenging managerial role is on improving and increasing the production of complex, high value disposable devices for US and international markets.
You’ll be responsible for managing a team of Group Leaders, Assemblers, and Technicians in a controlled clean room manufacturing environment. As the leader, you will provide strategic as well as hands-on, walk the manufacturing floor guidance to a talented team in assembly, test, evaluation and packaging in conformance to FDA, ISO and international regulatory standards. You would also assist manufacturing engineers in developing new and improved procedures and processes. As a highly visible manager you would provide leadership, interface, and support for peers in other departments including QA, Materials Management, and Finance.
- Prioritize, plan and lead efficient Class 3 medical device manufacturing activities.
- Provide direction and administrative support to Group Leaders, Assemblers and Technicians.
- Supervise and maintain the daily production schedule, including cost effective staffing requirements.
- Supervise the assembly of components into complex sub-assemblies and finished goods.
- Understand and interpret production drawings and procedures and train staff to use them in building and packaging products for sterilization processing.
- Collaborate closely with engineers to drive process improvements.
- Work with Materials Administrator to ensure adequate supply to reflect supplier lead times.
- Assure compliance with QA, FDA, ISO and other international manufacturing procedure and policy regs.
- Assist engineers in formulating tests, calibrations and procedures to maintain accuracy of devices.
- Set up standard and special lab equipment to test and evaluate devices at different stages of assembly.
- Prepare documentation including DHRs, pouch and box labels, and inspection forms in advance of assembly, packaging, and sterilization operations.
- Communicate daily with VP Operations all pertinent manufacturing, quality, and administrative activities, including process, scheduling, equipment and/or material issues.
- Display original thinking, creativity and resourcefulness in manufacturing.
- BS in a relevant discipline.
- A minimum of 15 years’ experience in a highly regulated manufacturing environment, with at least 10 of those years as a manager in a Class 2 or 3 disposable medical device manufacturing role.
- Successful experience in small and growing organizations is plus.
- Willing and able to work directly with staff on the factory floor, as well as the executive suite.
- Solid, well documented knowledge and application of FDA QSR, ISO 13485, and the MOD process.
- Ability to read and understand SOP’s and manufacturing procedures.
- Excellent verbal and written communication skills.