DescriptionPosition Summary: This position is primarily responsible for leading, directing, and optimizing day-to-day manufacturing operations within our high-tech medical device contract manufacturing facility as dictated by Cirtec's business needs. Operating under strict ISO 13485 and FDA regulations, this role oversees the production of cutting-edge thin-film and microelectronics products. You will lead a diverse team of operators and technicians performing intricate manual assembly, precision machine operation, and rigorous quality inspection. Your primary mandate is to foster a safety-first culture while meeting or exceeding SQDC (Safety, Quality, Delivery, Cost) and 5-S deliverables. You will leverage Lean Manufacturing principles to drive continuous improvement and achieve company-wide goals and objectives. The position heavily utilizes key performance indicators (KPIs) and visual factory management tools to track performance transparently on the shop floor. Additionally, the role is responsible for consistently communicating expectations and holding the production team accountable to maintaining world-class Good Manufacturing Practices (GMPs). Essential to this role is ensuring all production activities, material transactions, and compliance metrics are meticulously documented within core enterprise business systems, including but not limited to ERP, MES, PLM, HRIS, and training software.
Key Responsibilities:- Responsible for ensuring conformance to the Company's quality system in accordance with ISO 13485, company, and customer requirements.
- Maintains conformance to all other Company policies, procedures and work instructions.
- Plan and schedules work assignments to meet customer commitments including effective scheduling of overtime and paid time off.
- Determines ongoing employee resource requirements based upon production schedules, customer commitments and equipment capacity.
- Assures safe employee work practices, hazardous material handling, and good housekeeping in compliance with company policy, 5-S standards, and Federal/State regulations.
- Uses company ERP, MES, and related business systems to monitor shop floor transactions to completeness, correctness, and compliance.
- Full understanding of all equipment and facility systems and escalate problems quickly when identified.
- Leads cross functional meetings and share production plans, results, and support requirements from other departments.
- Interviews, recommends, and selects candidates for employment.
- Identifies and provides training, and development in verified software systems as required to ensure a competent workforce.
- Demonstrate a high level of professionalism, competence, and communication to effectively lead tours of the production floor for management, customers, etc.
- Effectively manages and evaluates employee performance. Motivates, coaches, counsels and disciplines employees to ensure maximum organizational effectiveness and accountability to world-class GMPs.
- Coordinate with product development and manufacturing transfer project teams to provide guidance of design for manufacturability, process development, and product launches.
- Communicate effectively with all functional managers.
- Takes a leadership role in continuous improvement activities
- Promotes the culture of Lean Manufacturing, Six Sigma, 5-S, and Teamwork.
- Supports Quality during FDA, ISO 13485, and customer audits by managing and providing compliant QMS documentation.
- Meets Safety, Quality, Delivery, and Cost deliverables in a timely manner.
Must Have:- Bachelors Degree required
- 1-3 years of experience in a management position
- 5-10 years of experience in an ISO 13485 medical device manufacturing environment or similarly regulated environment
- Demonstrated initiative and track record of improving manufacturing processes.
- Proficient in Microsoft office and manufacturing business systems such as ERP, Training Software, and MES.
- Ability to understand and assist in production scheduling/forecasting
- Must be able to read, write, and speak fluent English.
- Excellent organizational skills and strong communication skills.
- Ability to work independently
Good to have:- 3-5 years of experience working in a lean manufacturing environment, lean certification preferred
Salary Range: 90,000 to 130,000 based on skills and experience.
