We are working on an exciting opportunity to join this Boston area commercial medical device combination product company. Our client uses its proprietary technology platform to support a broad pipeline of products, with an initial focus on pancreatic insufficiency which results in malabsorption common in digestive cancers, and other serious diseases.
Responsibilities:
Manage a team of sustaining engineering resources to support day-to-day high volume production in cGMP environments ensuring continuity within the value stream, and meeting quality and production metrics.
Work with external supplier's value stream support team ensuring prioritization of projects, resource allocation, and execution of tasks such that corporate goals and objectives are realized.
Lead internal and external teams by using strong technical skills and tools to structure root cause investigations. Continuously improve processes and ensure robust process capabilities. Apply statistical methods and tools to support root cause investigation and process validations.
Institute robust and safe commercial production processes by prudent use of Metrics, Control Plans, Hazard Analysis, FMEAs, and other performance and risks assessment tools.
Develop the yearly department budget and track performance.
Experience:
BS in relevant technical/engineering/scientific discipline.
5+ years' experience in high volume/manufacturing/relevant environmental.
Minimum of 3 years overseeing in-house and/or outsourced medical device manufacturing.
Strong understanding of technical/scientific challenges that apply to continuous improvement programs and production processes used in the manufacture of medical devices and the subsequent packaging of those products.
Strong cGMP skills specific to medical devices, food, or pharmaceutical environments. Understanding of ISO 13483 and Human Food Program (HFP) requirement for medical Device and Food Contact applications.
Established record with evidence of project management, investigation and root cause analysis, problem solving, success through collaboration, leadership/accountability, and communication skills.