Operations Specialist, Device Manufacturing

About the Job:

The Operations Specialist, Device Manufacturing is responsible for the compliant and timely execution of Device Manufacturing operations, including manufacturing of controlled kitting activities that enable FMI's internal production processes. This position serves as a key operational resource for production readiness, work order execution, material verification, labeling and reconciliation, documentation, release coordination, and rework activities.

The Operations Specialist, Device Manufacturing sequences assigned work, provides technical guidance, and serves as a subject matter expert for manufacturing and kitting processes, documentation, and quality requirements. The role partners with cross-functional teams to drive process improvements, support manufacturing readiness, and ensure compliant and efficient Device Manufacturing operations. The position maintains proficiency across multiple workflows to support operational continuity and evolving business needs.

Key Responsibilities:

• Regular onsite work at a designated FMI location is an essential function of the role. Work arrangements and onsite requirements may vary based on production volume, training, quality events, and other operational needs.
• Lead and perform kitting activities in accordance with approved procedures, specifications, and manufacturing records.
• Sequence assigned work, confirm production readiness, and communicate material, capacity, quality, or documentation risks.
• Execute and document kit assembly, packaging, labeling and reconciliation, verification, inventory transactions, release activities, and rework.
• Generate and maintain work orders, Device History Records, and supporting production documentation, and accurately record production and material transactions in approved ERP and manufacturing systems.
• Review manufacturing records for accuracy, completeness, traceability, and compliance.
• Serve as the kitting subject-matter expert and author or revise associated procedures, work instructions, forms, and training materials.
• Identify and escalate potential quality events; pause work and protect affected material or product when quality or compliance may be at risk.
• Support investigations, change controls, risk assessments, validation, audits, product introductions, system changes, and process improvements.
• Train and cross-train colleagues, maintain required qualifications, and develop proficiency in additional Device Manufacturing workflows to support operational continuity.
• Collaborate with cross-functional partners, comply with FMI’s attendance policies, and complete other duties appropriate to the role.
• Comply with FMI's attendance policies

Qualifications:

Basic Qualifications:

• High school diploma and 7 years of relevant experience; Associate degree and 5 years of relevant experience; or Bachelor’s degree and 3 years of relevant experience
• 2 or more years of experience in a regulated manufacturing, medical device, diagnostics, biotechnology, pharmaceutical, laboratory, or comparable environment
• Familiarity with ERP systems such as SAP, Oracle, JD Edwards, NetSuite, Maximo, or comparable platforms

Preferred Qualifications:

• Bachelor’s degree in engineering, supply chain, operations, life sciences, manufacturing, quality, business, or a related field
• Experience with kitting, assembly, packaging, labeling, inspection, material handling, production, or a comparable operation
• Experience executing controlled documentation and using enterprise manufacturing, inventory, laboratory, or quality systems
• Knowledge of quality systems, Good Manufacturing Practices, Good Documentation Practices, investigations, change control, risk management, or validation
• Experience with medical-device or in-vitro diagnostic manufacturing, including controlled kitting, labeling, reconciliation, or batch production
• Experience coordinating work, training colleagues, supporting cross-training, and authoring controlled documents
• Experience with regulated enterprise systems and Lean or other continuous-improvement methods
• Demonstrated ability to organize work, interpret controlled requirements, communicate effectively, and escalate risks appropriately
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI’s values: Integrity, Courage, and Passion

The expected salary range for this position based on the primary location of Boston, MA is $77,350 - $96,700 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.