Device Manufacturing Operations & Kitting Specialist

Foundation Medicine; Boston (MA); On-site; USD 77,000 - 97,000; Full time

Job summary

Foundation Medicine is seeking an Operations Specialist, Device Manufacturing to ensure compliant and timely execution of device manufacturing operations, including controlled kitting activities supporting internal production processes.

The role sequences work, provides guidance, and collaborates with cross-functional teams to improve processes, maintain readiness, and ensure compliance across multiple workflows.

Qualifications

• 7 years of relevant experience (or 5 with an Associate, or 3 with a Bachelor’s degree)
• 2+ years in a regulated manufacturing, medical device, diagnostics, biotech, pharmaceutical, laboratory, or similar environment
• Familiarity with ERP systems such as SAP, Oracle, JD Edwards, NetSuite, Maximo, or similar platforms

Responsibilities

• Regular onsite work at a FMI location is required.
• Lead and perform kitting activities per procedures and records.
• Sequence work, confirm production readiness, and communicate risks.
• Execute and document kit assembly, packaging, labeling, reconciliation, verification, inventory transactions, release, and rework.
• Generate and maintain work orders, Device History Records, and production documentation.

Education

Bachelor's degree in related field

Associate degree in related field

High school diploma

Tools

SAP

Oracle

JD Edwards

NetSuite

Maximo

Job description

Foundation Medicine is seeking an Operations Specialist, Device Manufacturing to ensure compliant and timely execution of device manufacturing operations, including controlled kitting activities supporting internal production processes.

The role sequences work, provides guidance, and collaborates with cross-functional teams to improve processes, maintain readiness, and ensure compliance across multiple workflows.