This role provides the strategy, leadership and managerial oversight for the Operations departments, main activities are to lead the product engineering department . Director of Operations will also be responsible for managing CM performance in liaison with corporate and site supply chain activities.
The Director of Operations will report directly to VP contract manufacturing in corporate and dotted reporting to Site leader. will be part of site leadership team and will have cross functional interaction with R&D and Quality organization in Israel and with the USA teams.
The Director needs to have strong leadership skill to lead the engineering and supply chain activities.
The Director needs to have a wide breadth and depth of technical, product and business background, an ability to partner across functional, business and geographic boundaries, and must be a progressive and passionate change agent. The role also requires a clear understanding and working knowledge of Continuous Improvement (CI) and Value Analysis and Value Engineering (VAVE) methodologies, program management practices, manufacturing/test processes and technologies, and product development and change processes.
•Provide the vision, strategy, and leadership for the Engineering department to support the business needs.
•Be part of the site leadership team
•Cross functional interface and support with R&D and Quality teams.
•Lead Product Engineering groups including:
o Sustaining Engineering
o Supplier Excellence
o Advanced Manufacturing. Engineering (NPI)
•Responsible to establish, maintain and improve process development capabilities to support new product development and product launches. Where necessary establish robust pilot line capabilities.
•Partner with the Design for Reliability and Manufacturability organization to ensure that Product Development teams prioritize highest quality, right cost, and shortest lead times.
•Develop and implement strategies to further transform Operations into a Global Operations organization supporting all Production. Support includes process assistance, test strategy support, product improvements to reduce cost & improve quality, supplier (external and vertical) issues & improvements.
•Coordinate engineering functions and resources to implement tactical plans that are directly linked to business and operational objectives.
•Has overall responsibility for the execution of CI/VAVE projects, engineering-centric critical supply projects, a multitude of test support activities and equipment preventive maintenance
•Manage department financials, projects, physical resources and personnel.
•Ensure the quality policy/system is planned, understood, implemented and maintained by ensuring compliance within the department.
•Ensure departmental compliance as well as appropriate departmental resources are available to effectively maintain the quality system (people, facilities, tools, and training).
Bachelor’s degree in a related technical discipline, and 10+ years of experience with product development and/or support and continuous improvement OR
Master’s degree in a related technical discipline and 8+ years of product development and/or support and continuous improvement.
7+ years of leadership experience
5+ years experience in medical device industry or other highly regulated industry
DESIRED/PREFERRED QUALIFICATIONS (optional):
Knowledge of quality systems, products, manufacturing and test processes, and general medical device marketplace.
Progressive leadership experience driving continuous improvement.
Professional demonstration and aptitude for coordinating large number of simultaneous priorities, projects, complex problems, and strategic initiatives
Professional experience in multidisciplinary, Robotics, mechanics instruments, test equipment and other internal and external medical device components and subassemblies.
Complex project, department and personnel management experience.
Deep understanding of Quality Systems including validation, change control, and regulatory submission
Strong knowledge of FDA and other global regulatory requirements for medical devices
Travel up to 25% of time including internationally.