Director of Operations

📋 Description

• Lead cross-functional programs driving on-time, on-budget manufacturing execution.
• Optimize production processes, capacity, and throughput with leadership.
• Support IQ/OQ/PQ, equipment qualification, and line readiness for new/existing products.
• Drive Lean, Six Sigma, Kaizen, and Value Stream Mapping for continuous improvement.
• Coordinate with Supply Chain for material readiness and inventory targets.
• Lead production hand-off from development to commercial manufacturing.

🎯 Requirements

• Bachelor's degree in Engineering or related technical discipline.
• 6–9 years in program/operations within medical devices.
• Managed complex, cross-functional programs from initiation to commercialization.
• Hands-on experience supporting medical device manufacturing operations.
• FDA 21 CFR Part 820, ISO 13485, ISO 14971, and design controls for Class II devices.
• Familiarity with 510(k) submissions and post-market regulatory obligations.

🎁 Benefits

• Medical, dental and vision plans
• STD, LTD, and insurance plans
• HSA and Flexible Spending Accounts
• Safe Harbor 401(k) with 3% employer contribution
• FlexVTO (flexible vacation plans), sick leave, 11 company holidays
• Home Office Benefits Stipend