Manufacturing Operations Specialist

Title: Manufacturing Operations Specialist

Location: Boston, MA - onsite (Woburn)

Contract Length: 5 months

Hours: 40 hours (8-4/5)

Start: 2nd February

W2 only

Key Responsibilities

Manufacturing Operations

• Oversee daily production activities for electromechanical medical devices, ensuring throughput, quality, and compliance.
• Support manufacturing line readiness, including equipment setup, calibration, and preventive maintenance coordination.
• Troubleshoot and resolve manufacturing issues in collaboration with engineering, quality, and supply chain teams.

Process Optimization & Technical Support

• Lead root‑cause investigations and implement corrective/preventive actions (CAPA).
• Identify opportunities for process improvements to enhance efficiency, reduce defects, and optimize assembly workflow.
• Support pilot builds, validation runs, and scale‑up activities.

Documentation & Compliance

• Create and update manufacturing documentation (work instructions, SOPs, assembly guides).
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and internal quality requirements.
• Support validation activities (IQ/OQ/PQ) for equipment and processes.

Supplier & Cross‑Functional Collaboration

• Engage with external manufacturing partners and component suppliers to manage build quality and material availability.
• Collaborate with R&D for design transfer and manufacturability improvements (DFM).
• Participate in change control processes and risk assessments (e.g., FMEA).

Required Experience

• 5+ years of experience in manufacturing operations within the medical device industry, specifically electromechanical or electro‑mechanical assemblies.
• Strong hands-on knowledge of mechanical assembly, PCB integration, wiring, and device testing.
• Experience with FDA-regulated production environments and ISO 13485 QMS.
• Proven ability to interpret engineering drawings, BOMs, schematics, and test procedures.
• Background in problem-solving tools (5 Whys, Ishikawa, DMAIC).
• Experience supporting contract manufacturers or external assembly partners is a plus.

Key Skills

• Manufacturing operations management
• Electromechanical device assembly
• Root cause analysis & CAPA
• Process development & optimization
• ERP/MRP systems knowledge
• Equipment validation and process validation
• Strong communication and documentation skills
• Ability to work cross‑functionally in a fast-paced environment

Education

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field (or equivalent industry experience).