Director, Manufacturing and Operations

Cambridge, MA

Our client is a growing medical device therapeutics company working with world-class partners to develop unique and disruptive therapies that will have an immediate impact by saving lives on a global scale.
This role is responsible for providing leadership of internal manufacturing and service operations including contract manufacturing partners. Working closely with internal teams and external partners, this role will provide management, direction and oversight with a focus on continuous improvement and driving delivery aligned with the goals of the business.


• Assess and drive process for selecting inhouse manufacturing vs. CMO decisions, as well as service structures and approaches, based on financial, risk and business goals
• Implement quality, compliance and infrastructure elements and processes to support manufacturing and service organizations in accordance with world-wide, medical device requirements
• Directly establish and support design for manufacturability, design for assembly and design for cost activities in conjunction with engineering design and development teams
• Lead procurement and supply chain operations
• Participate in project development team activities, as a core team member, to support development, management and execution of realistic plans for product development, launch and support
• Accountable for continuous improvement initiatives including establishment of KPI’s, project planning and execution
• Work with external distribution and sales partners to establish, support and drive manufacturing and service functions
• Assist company officers and senior staff members in the development and formulation of long and short-range planning, policies, programs and objectives
• Accountable for recognizing opportunities for cost savings and implementing actions to realize these savings
• Provide leadership in implementing training for important topics such as risk mitigation, safety protocol and industry best practices


• A minimum of a Bachelor’s Degree in Engineering; Advance Degree desired
• At least ten years of experience in manufacturing and service operations for FDA Class II medical device and disposable products, FDA Class III a plus. Direct experience and proven track record in establishing from the ground up, manufacturing and service organizations and CMO partnerships
• Strong understanding of systems and processes, combining critical thinking with industry expertise to optimize production
• Extensive experience with manufacturing process improvement, including budget management, facility enhancement and improvements, lead time reduction, workflow enhancements and capacity management planning
• Experience and training in recognized quality system elements such as Statistical Process Control, Six Sigma, Total Quality Management, Lean Manufacturing and/or ISO processes
• Strong financial acumen, demonstrated strategic planning skills and the ability to successfully communicate and operate in a fast moving, startup organization

Inquiries and resumes to:

Kathy Provost at or 978/952-6425

For more information, visit

May, 23, 2019