Production Manager – Medical Devices

Freudenberg Medical - Louisville, KY3.6

Full-timeEstimated: $78,000 - $100,000 a year
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EducationSkillsBenefits
The Freudenberg Group, a global technology group with 48,000 employees in some 60 countries, develops leading-edge technologies, and excellent products, solutions and services for more than 30 market segments. Freudenberg & Co. Kommanditgesellschaft, with its Headquarter in Weinheim, is the strategic parent company of the broadly diversified Group. Freudenberg Medical is a leading global manufacturer of components for medical devices, complex catheter systems for minimally-invasive surgery and total solutions for the biotech, healthcare and pharmaceutical industries.

Production Manager – Medical Devices
Previous experience in regulated industry in leading a production team focused on complex assembly
Your tasks
Provide leadership, goal-setting, communications, and facilitation skills to guide and motivate project personnel and develop strong work ethic for the team.
Management and Leadership Responsibilities
Set clear expectations and objectives for each employee. Create alignment with the company’s guiding principles, policy deployment process, annual operating plan, and department objectives.
Facilitate the development, training, and advancement of direct reports, and create a clear succession plan in your area of responsibility.
Develop top performers and provide opportunities for training and education along with mentoring.
Department Responsibilities
Work with Product Development to transfer new products seamlessly into production. As required, work with Product Development to establish appropriate metrics that must be met before the transfer process is completed and the PD team is released. Potential metrics include, but are not limited to, process yields, productivity (e.g., devices/person/hr), and equipment downtime.
Act as the company’s primary customer interface for assigned product lines. Create an open relationship with the customer and a culture of anticipating, understanding, and exceeding our customers’ needs and expectations.
Execute the five lean principles in your areas of responsibility: Specify Value, Map the Value Stream, Make value Flow, Let the customer Pull product, Refine the system to Perfection
Ensure all productions lines are managed using GROWTTH tools and employees understand that and act accordingly. Specific lean actions include:
Conduct daily meetings on the line to review the previous day’s production, any issues, and projected activities including support functions.
Establish a daily production scheduling process that allows each line to schedule their own builds to meet customer needs.
Work with GROWTTH leadership to implement and maintain visual controls, including MDI boards tracking hourly goals, actual hourly results, and documentation of problems and scrap issues and the associated status or corrective action and other metrics. Any down time, set-up time, and shut down time should be captured so that the team can review and try and minimize for the future. Ensure this data is captured and trended for manufacturing metrics.
Ensure that associates are provided with clear manufacturing instructions and standards of work to drive improvements in the quality of the products. Implement standard work wherever possible.
Drive associates to be cross trained on each operation on their line. Ensure a training matrix is posted and maintained.
Improve product, process, and paperwork quality by incorporating the following activities:
Make elimination of product defects a top priority.
Support customer, notified body, regulatory agency, and internal audits by providing resources as required.
Ensure department is compliant with all applicable Quality policies and regulations.
Track scrap, prioritize actions, and track results on a daily basis.
Drive teams towards identification of root causes of manufacturing issues. If a CAPA is issued then ensure the item is closed in an appropriate amount of time.
Ensure your Quality Engineer(s), Manufacturing Engineer(s) and Technician(s) are responding to and solving customer complaints.
Ensure Quality Engineer(s) present customer complaint data and actions to the production cell team (including associates).
Apply GROWTTH principles to the management of raw materials, subassembly, and finished goods inventory. Examples include:
Establish processes that speed acceptance of raw material and movement through receiving inspection and into the Controlled Environment with a minimal amount of transactions and cost.
Establish a Visual Inventory Management system to provide raw materials to the production floor.
Establish metrics and ensure that the buyer/planner drives the organization and our suppliers towards an increased number of components on a kanban system.
Create quotes for non-recurring engineering charges to support production changes.
Our expectations
Bachelor’s degree in Engineering, Manufacturing or related field
A minimum of 5 years of manufacturing management experience or equivalent in regulated industry such as medical device and/or healthcare products manufacturing in an engineering and production/assembly environment
FDA Quality System Regulation, ISO 13485 and design control experience preferred.
Successful experience leading and developing functional teams and organizational talent
Experience using SAP ERP software
Experience in a metric driven culture specific experience in LEAN principles with an ability to be White and Green Belt certified within 12 months of start date.
Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work.
Trustworthy, discrete and a high degree of personal integrity to maintain sensitive and confidential information
Accurate and attention to detail
Leadership ability and organizational skills.
Proficiency in the use of PC and programs, particularly Project, Excel, Word, PowerPoint.
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) both to senior management, customers and associates
Ability to travel as required (10%)

Preferred Qualifications

MBA degree or the educational equivalent
Freudenberg Medical is a global partner for the design, development, and manufacture of innovative medical device technologies. We offer the following services medical device, pharmaceutical and IVD clients worldwide product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services.

For nearly 30 years, medical device and healthcare companies around the world have looked to Freudenberg Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Freudenberg Medical maintains design and manufacturing centers in California, Indiana, Massachusetts, Minnesota, Costa Rica, Europe and Asia.

Freudenberg Medical manufactures minimally invasive, handheld and catheter-based devices out of our 93,000 square foot state-of-the-art facility, strategically and centrally located in Jeffersonville, Indiana. Freudenberg Medical’s culture is positive and team oriented. In our environment we like to have fun while helping others with our cutting edge medical devices. Our company is very driven to lead in the medical device industry to improve the quality of life of the patients we serve.

Freudenberg Medical is a local, innovative, high growth company with a collaborative, high performance work environment. We develop and manufacture minimally invasive, single use medical devices in the endoscopy, cardiovascular, neurovascular, and urology markets. The products we develop and manufacture are typically market disruptive and displace higher cost procedures.

Location: Jeffersonville, IN (near Louisville, KY)

We are looking for a Production Manager who is:
Driven and focused to manage Production/Operations, utilizing GROWTTH (Get Rid Of Waste Thru Team Harmony)/ Lean principles including interfacing with customers and managing resources.
A leader with a strong sense of business acumen including financial analysis focused on the success of the group along with a desire to continuously learn and develop.
An energetic and dependable leader who enjoys developing innovative medical device products and fostering accountable teams in production. Must have previous manufacturing supervisory experience.
Self-motivated and thrives in a fast –paced, cutting-edge environment with initiative to be proactive and seek out opportunities for improvement.
It’s an exciting time to work at Freudenberg Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match.