Operations Manager

Cepheid Morrisville , NC 27560

Posted 2 weeks ago

The Operations Manager will drive ever-improving results focusing on manufacturing operations and global supply chain by leveraging DBS tools, consulting skills, and change management process interacting with the additional Leica plants globally.

The Operations Manager is responsible for the production of Optical Coherence Tomorgraphy imaging systems and accessories, including all aspects of manufacturing and production of released products, pilot builds of new products, and hardware and software upgrades to existing products.

The Operations Manager is responsible for key performance metrics including quality, cost, on time delivery and supplier performance and is expected to maintain strong and productive interfaces to development, product management, regulatory & quality, sales and suppliers. In this role, the Operations Manager will stress DBS tools like Daily and Visual Management techniques to improve clarity and drive execution based on timelines, milestones and priorities across the team and works with Global Operations and other leaders to define a go forward footprint strategy.

The individual will be responsible for scheduling and providing clarity on resource allocations and resource gaps, and developing schedules to track expenditures to budget.

KEY RESPONSIBILITIES (include but not limited to)

Production Management

  • Drive ever-improving results by leveraging DBS tools, consulting skills, and change management process. In scope are the operational and transactional processes within our manufacturing, supply chain, quality assurance and customer services related to the Morrisville facility.

  • Work with global leadership team to drive execution of the key initiatives for lean conversion, gross margin improvements, benchmark and incorporate best practices.

  • Assist in planning and ensure execution of productive kaizen events. Promote and facilitate diagnosis of work flow impediments and other wastes throughout the OCT operations.

  • Promote and facilitate associate development in various DBS tools, lean production, and kaizen leadership.

  • Direct and manage production team to perform manufacturing, quality control, production scheduling, materials control, in order to meet customers' orders in time

  • Supports R&D project teams and is responsible for implementing new projects into production based on project timeline and priorities

Quality Management

  • Revise manufacturing procedures as necessary to reflect current practices, streamline processes, and improve efficiency in accordance with ISO 13485.

  • Ensure manufacturing generated documentation adheres to the Quality System and is recorded accurately.

  • Guide and support RA/QA department in monitoring of product complaints and support CAPA execution across the teams

Organization Development / Plant Performance

  • Ensure production and delivery of the highest quality product with predictable lead times.

  • Manage manufacturing capacity to meet projected demand in close cooperation with commercial and financial staff.

  • Supervise production, quality control, and manufacturing engineering staff to ensure process and function effectiveness and efficiency.

  • Lead and monitor plant performance through direct involvement, team development, coaching, establishment of goals and good countermeasure practices.

  • Participate in lean manufacturing initiatives and initiate ECNs for backlogged changes

Supply Chain

  • Manage just-in-time inventory levels and maintain accurate and timely system for inventory activity reporting.

  • Execute and oversee purchasing processes

  • Manage inbound and outbound logistics associated with manufacturing and customer support

  • Manage relationships with vendors to ensure control of costs, quality of parts and stability of supply. Negotiate with strategic vendors for custom components, devices and modules.

  • Bachelor's Degree in Engineering or Engineering Management, Operations or equivalent technical field of study

  • Minimum of 6 years' experience in Commercial Operations, Manufacturing Operations

  • Minimum of 4 years' technical product development experience

  • Experience managing or leading a team

  • Direct experience working in the medical device industry or similar highly regulated environment

  • Experience with MS tools including MS project and excel

  • Experience with CAD, SolidWorks preferred

  • Experience leading numerous successful projects (delivered on-time, meeting product requirements and cost target), including some complex projects, and projects involving a number of project members and customers

  • Good working knowledge of product design (mechanical / electronics / software) is essential

  • Good mechanical aptitude

Leica Microsystems Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

Diversity & Inclusion

At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page

Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.


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VIEW JOBS 3/16/2019 12:00:00 AM 2019-06-14T00:00 The Operations Manager will drive ever-improving results focusing on manufacturing operations and global supply chain by leveraging DBS tools, consulting skills, and change management process interacting with the additional Leica plants globally. The Operations Manager is responsible for the production of Optical Coherence Tomorgraphy imaging systems and accessories, including all aspects of manufacturing and production of released products, pilot builds of new products, and hardware and software upgrades to existing products. The Operations Manager is responsible for key performance metrics including quality, cost, on time delivery and supplier performance and is expected to maintain strong and productive interfaces to development, product management, regulatory & quality, sales and suppliers. In this role, the Operations Manager will stress DBS tools like Daily and Visual Management techniques to improve clarity and drive execution based on timelines, milestones and priorities across the team and works with Global Operations and other leaders to define a go forward footprint strategy. The individual will be responsible for scheduling and providing clarity on resource allocations and resource gaps, and developing schedules to track expenditures to budget. KEY RESPONSIBILITIES (include but not limited to) Production Management * Drive ever-improving results by leveraging DBS tools, consulting skills, and change management process. In scope are the operational and transactional processes within our manufacturing, supply chain, quality assurance and customer services related to the Morrisville facility. * Work with global leadership team to drive execution of the key initiatives for lean conversion, gross margin improvements, benchmark and incorporate best practices. * Assist in planning and ensure execution of productive kaizen events. Promote and facilitate diagnosis of work flow impediments and other wastes throughout the OCT operations. * Promote and facilitate associate development in various DBS tools, lean production, and kaizen leadership. * Direct and manage production team to perform manufacturing, quality control, production scheduling, materials control, in order to meet customers' orders in time * Supports R&D project teams and is responsible for implementing new projects into production based on project timeline and priorities Quality Management * Revise manufacturing procedures as necessary to reflect current practices, streamline processes, and improve efficiency in accordance with ISO 13485. * Ensure manufacturing generated documentation adheres to the Quality System and is recorded accurately. * Guide and support RA/QA department in monitoring of product complaints and support CAPA execution across the teams Organization Development / Plant Performance * Ensure production and delivery of the highest quality product with predictable lead times. * Manage manufacturing capacity to meet projected demand in close cooperation with commercial and financial staff. * Supervise production, quality control, and manufacturing engineering staff to ensure process and function effectiveness and efficiency. * Lead and monitor plant performance through direct involvement, team development, coaching, establishment of goals and good countermeasure practices. * Participate in lean manufacturing initiatives and initiate ECNs for backlogged changes Supply Chain * Manage just-in-time inventory levels and maintain accurate and timely system for inventory activity reporting. * Execute and oversee purchasing processes * Manage inbound and outbound logistics associated with manufacturing and customer support * Manage relationships with vendors to ensure control of costs, quality of parts and stability of supply. Negotiate with strategic vendors for custom components, devices and modules. * Bachelor's Degree in Engineering or Engineering Management, Operations or equivalent technical field of study * Minimum of 6 years' experience in Commercial Operations, Manufacturing Operations * Minimum of 4 years' technical product development experience * Experience managing or leading a team * Direct experience working in the medical device industry or similar highly regulated environment * Experience with MS tools including MS project and excel * Experience with CAD, SolidWorks preferred * Experience leading numerous successful projects (delivered on-time, meeting product requirements and cost target), including some complex projects, and projects involving a number of project members and customers * Good working knowledge of product design (mechanical / electronics / software) is essential * Good mechanical aptitude Leica Microsystems Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. Diversity & Inclusion At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. Radiometer Morrisville NC

Operations Manager

Cepheid