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Sustaining Engineering Manager

Priority Search Inc
Watertown, MA Full Time
POSTED ON 2/20/2025
AVAILABLE BEFORE 5/18/2025

This is an exciting and unique opportunity to join this growing Boston area medical device company dedicated to developing and commercializing products designed to address challenges of people with gastrointestinal disorders and rare 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 suppliers 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 Engineering / scientific discipline.
  • 5 years experience in high volume / manufacturing / relevant environmental.
  • 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.
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    Job openings at Priority Search Inc

    Priority Search Inc
    Hired Organization Address Waltham, MA Full Time
    This is an exciting and unique opportunity to join this growing Boston area combination medical device company dedicated...

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